Trial Outcomes & Findings for Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. (NCT NCT02903771)
NCT ID: NCT02903771
Last Updated: 2024-09-19
Results Overview
Determination of the MTD: At each dose level, the number and proportion of patients in the MTD population who experience a dose-limiting toxicity (DLT) during the DLT evaluation period (Cycle 1/Part A) of Cantrixil using standard safety monitoring assessments when administered as a monotherapy. The MDT was the dose level below the cohort in which 1 or more patients had experienced a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
During Cycle 1 (21 days)
Results posted on
2024-09-19
Participant Flow
Participants were recruited based on physician referral at 6 centres in 2 countries (USA and Australia) between December 2016 and March 2020. The first patient was enrolled on 05 December 2016 and the last patient was enrolled on 30 July 2019.
A total of 32 patients consented to participate, 5 patients failed screening and 2 did not receive any study drug. A total of 25 patients received at least one dose of study drug.
Participant milestones
| Measure |
Cantrixil 0.24 mg/kg
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mk/kg
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5.0 mg/kg
Participants received Cantrixil 5.0 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Part A: Dose Escalation Cohort
STARTED
|
2
|
1
|
1
|
1
|
3
|
2
|
1
|
|
Part A: Dose Escalation Cohort
COMPLETED
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Part A: Dose Escalation Cohort
NOT COMPLETED
|
1
|
1
|
1
|
0
|
1
|
2
|
1
|
|
Part B: Expansion Cohort (5 mg/kg)
STARTED
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
12
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cantrixil 0.24 mg/kg
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mk/kg
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5.0 mg/kg
Participants received Cantrixil 5.0 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Part A: Dose Escalation Cohort
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part A: Dose Escalation Cohort
Progressive disease
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Dose Escalation Cohort
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Part A: Dose Escalation Cohort
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part A: Dose Escalation Cohort
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
Progressive disease
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B: Expansion Cohort (5 mg/kg)
Death due to progressive disease
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.
Baseline characteristics by cohort
| Measure |
Cantrixil 0.24 mg/kg
n=2 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=17 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 18.38 • n=99 Participants
|
70.0 years
STANDARD_DEVIATION 0 • n=107 Participants
|
66.0 years
STANDARD_DEVIATION 0 • n=206 Participants
|
66.0 years
STANDARD_DEVIATION 1 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 8.63 • n=31 Participants
|
65.0 years
STANDARD_DEVIATION 9.90 • n=30 Participants
|
46.0 years
STANDARD_DEVIATION 0 • n=3 Participants
|
62.5 years
STANDARD_DEVIATION 9.38 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Screening BMI (kg/m^2)
|
25.29 kg/m2
STANDARD_DEVIATION 8.27 • n=99 Participants
|
21.30 kg/m2
STANDARD_DEVIATION 0 • n=107 Participants
|
25.50 kg/m2
STANDARD_DEVIATION 0 • n=206 Participants
|
24.40 kg/m2
STANDARD_DEVIATION 0 • n=7 Participants
|
27.98 kg/m2
STANDARD_DEVIATION 5.76 • n=31 Participants
|
33.23 kg/m2
STANDARD_DEVIATION 7.14 • n=30 Participants
|
38.2 kg/m2
STANDARD_DEVIATION 0 • n=3 Participants
|
28.14 kg/m2
STANDARD_DEVIATION 6.061 • n=6 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active, able to carry on all pre-disease performance without restriction)
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restricted in physically strenuous activity but ambulatory and able to carry out work activities)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
IC
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
IIB
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
IIIA
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
IIIB
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
IIIC
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
IVA
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Tumor Stage at diagnosis
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Tumor Stage at Study Entry
IIIA
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Tumor Stage at Study Entry
IIIB
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Tumor Stage at Study Entry
IIIC
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
|
Tumor Stage at Study Entry
IVA
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
|
Tumor Stage at Study Entry
IVB
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Tumour Type
Ovarian Cancer
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
|
Tumour Type
Fallopian Tube Cancer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Tumour Type
Peritoneal Cancer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Histological Sub-Type
Serous Carcinoma
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
|
Histological Sub-Type
Endometrioid Carcinoma
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Histological Sub-Type
Clear Cell Carcinoma
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Histological Sub-Type
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Grade
Low grade
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Grade
High grade
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Prior lines of therapy
|
2.5 Number of lines of previous therapy
STANDARD_DEVIATION 0.71 • n=99 Participants
|
5.0 Number of lines of previous therapy
STANDARD_DEVIATION 0 • n=107 Participants
|
2.0 Number of lines of previous therapy
STANDARD_DEVIATION 0 • n=206 Participants
|
2.0 Number of lines of previous therapy
STANDARD_DEVIATION 0 • n=7 Participants
|
4.0 Number of lines of previous therapy
STANDARD_DEVIATION 2.78 • n=31 Participants
|
4.0 Number of lines of previous therapy
STANDARD_DEVIATION 2.83 • n=30 Participants
|
2.0 Number of lines of previous therapy
STANDARD_DEVIATION 0 • n=3 Participants
|
3.7 Number of lines of previous therapy
STANDARD_DEVIATION 2.48 • n=6 Participants
|
|
Prior bevacizumab
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Patient Sensitivity to Platinum
Platinum-Sensitive
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Patient Sensitivity to Platinum
Platinum-Resistant
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
|
Patient Sensitivity to Platinum
Platinum-Refractory
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Duration of Disease Diagnosis (months)
|
49.15 months
STANDARD_DEVIATION 31.75 • n=99 Participants
|
61.60 months
STANDARD_DEVIATION 0 • n=107 Participants
|
17.20 months
STANDARD_DEVIATION 0 • n=206 Participants
|
37.80 months
STANDARD_DEVIATION 0 • n=7 Participants
|
62.59 months
STANDARD_DEVIATION 56.33 • n=31 Participants
|
46.60 months
STANDARD_DEVIATION 8.63 • n=30 Participants
|
34.70 months
STANDARD_DEVIATION 0. • n=3 Participants
|
56.27 months
STANDARD_DEVIATION 47.950 • n=6 Participants
|
PRIMARY outcome
Timeframe: During Cycle 1 (21 days)Population: The MTD population included all patients who experienced DLTs in Cycle 1/Part A, and those who received all 3 weekly doses of study treatment in Cycle 1/Part A. The safety data regarding the Cycle 1/Part A were used to determine MTD from this analysis population.
Determination of the MTD: At each dose level, the number and proportion of patients in the MTD population who experience a dose-limiting toxicity (DLT) during the DLT evaluation period (Cycle 1/Part A) of Cantrixil using standard safety monitoring assessments when administered as a monotherapy. The MDT was the dose level below the cohort in which 1 or more patients had experienced a DLT.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=2 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=3 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Determination of the Maximum Tolerated Dose (MTD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1 (Monotherapy)Population: All enrolled patients who received at least 1 dose of study treatment and who had undergone at least 1 PK assessment.
Mean plasma concentration
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=2 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=17 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile
Time (h): 0.00
|
0.00 ng/ml
Standard Deviation 0.00
|
0.00 ng/ml
|
0.00 ng/ml
|
0.00 ng/ml
|
0.00 ng/ml
Standard Deviation 0.00
|
0.00 ng/ml
|
0.00 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 0.083
|
4.21 ng/ml
Standard Deviation 5.95
|
43.8 ng/ml
|
52.2 ng/ml
|
73.9 ng/ml
|
227 ng/ml
Standard Deviation 199
|
479 ng/ml
Standard Deviation 304
|
5350 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 0.5
|
7.84 ng/ml
Standard Deviation 1.68
|
62.4 ng/ml
|
84.9 ng/ml
|
202 ng/ml
|
279 ng/ml
Standard Deviation 173
|
1220 ng/ml
|
6100 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 1.00
|
10.9 ng/ml
Standard Deviation 3.13
|
53.8 ng/ml
|
—
|
217 ng/ml
|
262 ng/ml
Standard Deviation 149
|
1150 ng/ml
Standard Deviation 191
|
3830 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 2.00
|
13.1 ng/ml
Standard Deviation 7.51
|
41.2 ng/ml
|
54.6 ng/ml
|
227 ng/ml
|
256 ng/ml
Standard Deviation 161
|
1210 ng/ml
Standard Deviation 205
|
3200 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 4.00
|
14.0 ng/ml
Standard Deviation 5.86
|
24.8 ng/ml
|
—
|
187 ng/ml
|
207 ng/ml
Standard Deviation 114
|
1080 ng/ml
Standard Deviation 511
|
2400 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 6.00
|
15.0 ng/ml
|
13.2 ng/ml
|
41.2 ng/ml
|
162 ng/ml
|
170 ng/ml
Standard Deviation 107
|
1030 ng/ml
Standard Deviation 489
|
1040 ng/ml
|
|
Pharmacokinetic Profile
Time (h): 24.00
|
0.971 ng/ml
|
0.0535 ng/ml
|
2.28 ng/ml
|
6.08 ng/ml
|
24.2 ng/ml
Standard Deviation 17.1
|
20.7 ng/ml
Standard Deviation 17.5
|
65.6 ng/ml
|
PRIMARY outcome
Timeframe: Cycle 3, Day 1 (Cantrixil plus chemotherapy)Population: All enrolled patients who received at least 1 dose of study treatment and who had undergone at least 1 PK assessment.
Mean plasma concentration
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=2 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=17 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile
Time (h): 0.00
|
0.00 ng/ml
|
0.00 ng/ml
|
—
|
0.00 ng/ml
|
0.258 ng/ml
Standard Deviation 0.479
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 0.083
|
12.0 ng/ml
|
37.5 ng/ml
|
—
|
201 ng/ml
|
242 ng/ml
Standard Deviation 106
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 0.5
|
18.5 ng/ml
|
48.7 ng/ml
|
—
|
261 ng/ml
|
368 ng/ml
Standard Deviation 236
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 1.00
|
19.6 ng/ml
|
53.2 ng/ml
|
—
|
298 ng/ml
|
327 ng/ml
Standard Deviation 210
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 2.00
|
20.2 ng/ml
|
45.1 ng/ml
|
—
|
193 ng/ml
|
298 ng/ml
Standard Deviation 91.1
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 4.00
|
21.5 ng/ml
|
32.2 ng/ml
|
—
|
129 ng/ml
|
210 ng/ml
Standard Deviation 129
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 6.00
|
19.8 ng/ml
|
22.3 ng/ml
|
—
|
112 ng/ml
|
174 ng/ml
Standard Deviation 130
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 24.00
|
—
|
0.093 ng/ml
|
—
|
1.11 ng/ml
|
11.4 ng/ml
Standard Deviation 10.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 3, Day 8 (Cantrixil plus chemotherapy)Population: All enrolled patients who received at least 1 dose of study treatment and who had undergone at least 1 PK assessment.
Mean plasma concentration
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=2 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=17 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile
Time (h): 4.00
|
17.1 ng/ml
|
31.1 ng/ml
|
—
|
129 ng/ml
|
204 ng/ml
Standard Deviation 139
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 0.00
|
0.00 ng/ml
|
0.00 ng/ml
|
—
|
0.00 ng/ml
|
0.347 ng/ml
Standard Deviation 0.918
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 0.083
|
6.04 ng/ml
|
17.5 ng/ml
|
—
|
429 ng/ml
|
290 ng/ml
Standard Deviation 171
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 0.5
|
15.5 ng/ml
|
87.9 ng/ml
|
—
|
328 ng/ml
|
430 ng/ml
Standard Deviation 166
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 1.00
|
19.3 ng/ml
|
75.5 ng/ml
|
—
|
243 ng/ml
|
309 ng/ml
Standard Deviation 191
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 2.00
|
18.9 ng/ml
|
59.7 ng/ml
|
—
|
197 ng/ml
|
259 ng/ml
Standard Deviation 168
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 6.00
|
—
|
24.0 ng/ml
|
—
|
104 ng/ml
|
163 ng/ml
Standard Deviation 142
|
—
|
—
|
|
Pharmacokinetic Profile
Time (h): 24.00
|
—
|
0.0582 ng/ml
|
—
|
2.48 ng/ml
|
13.0 ng/ml
Standard Deviation 11.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to End of Study (maximum 36 weeks)Population: The Full Analysis Population (FAS) included all enrolled patients, from Part A and Part B, who received at least 1 dose of study treatment and from whom at least 1 post-baseline efficacy measurement was obtained. Of the 25 patients, 9 were excluded from efficacy analyses, these were from dose groups: 0.24 mg/kg \[n=1\], 5 mg/kg \[n=7\]), 20 mg/kg \[n=1\].
Tumors were assessment via radiological imaging (MRI or CT). The Gynecological Cancer Intergroup (GCIG) has published a detailed guidance on the criteria that could be used in clinical trial protocols to define progression and response in recurrent disease using Response Evaluation Criteria in Solid Tumours (RECIST 1.1) together with the serum marker CA-125 (Rustin et al., Int J Gynecol Cancer 2011;21: 419Y423 DOI: 10.1097/IGC.0b013e3182070f17). Validated algorithms were used to assess best overall response. These algorithms combine response criteria for CA125, target lesions (up to 5 measurable lesions, 2 per organ, as defined by RECIST 1.1), non-target lesions (include ascites and peritoneal thickening, which are not measurable by RECIST 1.1), and new lesions (Yes/No). Example: a best overall response of complete response (CR) required the following composite scoring: Target lesion, CR + Non-Target lesion, CR + New lesions, no + CA-125, Normal.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=10 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Disease Response
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Response
Partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Disease Response
Progressive disease
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Disease Response
Stable disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Study (maximum 36 weeks)Population: The Full Analysis Population (FAS) included all enrolled patients, from Part A and Part B, who received at least 1 dose of study treatment and from whom at least 1 post-baseline efficacy measurement was obtained. Of the 25 patients, 9 were excluded from efficacy analyses, these were from dose groups: 0.24 mg/kg \[n=1\], 5 mg/kg \[n=7\]), 20 mg/kg \[n=1\].
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum or the longest diameter of target lesion; or any new lesions (measurable or non-measurable) and Gynecological Cancer Intergroup (GCIG) criteria progression based on serum CA 125, as an increase equal to or greater than 2 the the upper limit of normal documented on 2 occasions.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=10 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival
RECIST 1.1
|
5.52 Months
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
1.18 Months
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
1.02 Months
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
—
|
3.06 Months
Interval 1.22 to
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
1.38 Months
Interval 1.38 to
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
—
|
|
Progression Free Survival
RECIST 1.1 and GCIG
|
5.52 Months
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
1.18 Months
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
1.02 Months
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
—
|
3.06 Months
Interval 1.22 to 7.92
|
1.38 Months
Interval 1.38 to
The upper 95% confidence limit was not estimable due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Baseline to End of Study (maximum 36 weeks)Population: The Full Analysis Population (FAS) included all enrolled patients, from Part A and Part B, who received at least 1 dose of study treatment and from whom at least 1 post-baseline efficacy measurement was obtained. Of the 25 patients, 9 were excluded from efficacy analyses, these were from dose groups: 0.24 mg/kg \[n=1\], 5 mg/kg \[n=7\]), 20 mg/kg \[n=1\].
Number of patients who experienced one or more paracentesis events
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=10 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Paracentesis Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and End of Therapy (maximum 36 weeks)Population: The Full Analysis Population (FAS) included all enrolled patients, from Part A and Part B, who received at least 1 dose of study treatment and from whom at least 1 post-baseline efficacy measurement was obtained. Of the 25 patients, 9 were excluded from efficacy analyses, these were from dose groups: 0.24 mg/kg \[n=1\], 5 mg/kg \[n=7\]), 20 mg/kg \[n=1\].
Concentration of CA-125 in peripheral blood
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=10 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
CA-125 Level
Baseline
|
28.00 U/mL
|
130.00 U/mL
|
5.00 U/mL
|
41.00 U/mL
|
487.76 U/mL
Standard Deviation 599.07
|
51.50 U/mL
Standard Deviation 60.1
|
—
|
|
CA-125 Level
End of therapy
|
42.00 U/mL
|
94.00 U/mL
|
7.00 U/mL
|
23.00 U/mL
|
1153.17 U/mL
Standard Deviation 1577.828
|
96.50 U/mL
Standard Deviation 108.187
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Monotherapy (up to 6 weeks), End of Combination Therapy (up to 24 weeks)Population: Stem cell marker analysis was conducted only amongst patients enrolled into PART A of the study. Data were not available for all patients, missing data were not imputed.
Clonogenicity of CETCs in peripheral blood and malignant ascites (if present), assayed using the MAINTRAC® CETC Count method by Genostics or similar methodology.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=3 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Clonogenicity of Circulating Epithelial Tumour Cells (CETC)
Baseline
|
73.0 Number of spheroid cells
|
0.0 Number of spheroid cells
|
2650.0 Number of spheroid cells
|
0.0 Number of spheroid cells
|
333.3 Number of spheroid cells
Standard Deviation 305.51
|
0.0 Number of spheroid cells
Standard Deviation 0.00
|
—
|
|
Clonogenicity of Circulating Epithelial Tumour Cells (CETC)
End of mono therapy
|
—
|
0.0 Number of spheroid cells
|
—
|
0.0 Number of spheroid cells
|
325.0 Number of spheroid cells
Standard Deviation 388.91
|
50.0 Number of spheroid cells
|
—
|
|
Clonogenicity of Circulating Epithelial Tumour Cells (CETC)
End of therapy
|
—
|
—
|
—
|
0.0 Number of spheroid cells
|
0.0 Number of spheroid cells
Standard Deviation 0.00
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Monotherapy (up to 6 weeks), End of Combination Therapy (up to 24 weeks)Population: Stem cell marker analysis was conducted only amongst patients enrolled into PART A of the study. Data were not available for all patients, missing data were not imputed.
Number of CETC in peripheral blood and malignant ascites (if present), assayed using the MAINTRAC® CETC Count method by Genostics or similar methodology.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 Participants
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 Participants
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=3 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 Participants
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 Participants
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Enumeration of Circulating Epithelial Tumour Cells (CETC)
Baseline
|
550.0 cells/mL
|
0.0 cells/mL
Standard Deviation 0.0
|
50.0 cells/mL
|
0.0 cells/mL
Standard Deviation 0.0
|
116.7 cells/mL
Standard Deviation 125.83
|
0.0 cells/mL
Standard Deviation 0.0
|
—
|
|
Enumeration of Circulating Epithelial Tumour Cells (CETC)
End of mono therapy
|
—
|
300.0 cells/mL
|
—
|
400.0 cells/mL
|
150.0 cells/mL
Standard Deviation 70.71
|
2200.0 cells/mL
|
—
|
|
Enumeration of Circulating Epithelial Tumour Cells (CETC)
End of therapy
|
150.0 cells/mL
|
—
|
—
|
0.0 cells/mL
|
233.3 cells/mL
Standard Deviation 104.08
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Monotherapy (up to 6 weeks)Population: Stem cell marker analysis was conducted only amongst patients enrolled into PART A of the study. Data were not available for all patients, missing data were not imputed.
Expression of stem cell markers ALDH in the isolated colonies will be measured using fluorescein isothiocyanate-labelled (FITC-labelled) or alternatively labelled antibodies and scanning fluorescent microscopy techniques.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
n=1 Participants
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 Participants
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=2 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Expression of Stem Cell Markers: Aldehyde Dehydrogenase (ALDH)
Baseline
|
100.0 Number of ALDH expressing cells
|
—
|
2650.0 Number of ALDH expressing cells
|
—
|
81.0 Number of ALDH expressing cells
|
—
|
—
|
|
Expression of Stem Cell Markers: Aldehyde Dehydrogenase (ALDH)
End of mono therapy
|
—
|
—
|
—
|
—
|
80.0 Number of ALDH expressing cells
Standard Deviation 28.28
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Monotherapy (up to 6 weeks)Population: Stem cell marker analysis was conducted only amongst patients enrolled into PART A of the study. Data were not available for all patients, missing data were not imputed.
Expression of stem cell markers CD44 in the isolated colonies will be measured using fluorescein isothiocyanate-labelled (FITC-labelled) or alternatively labelled antibodies and scanning fluorescent microscopy techniques.
Outcome measures
| Measure |
Cantrixil 0.24 mg/kg
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=2 Participants
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
Participants received Cantrixil 20 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Expression of Stem Cell Markers: CD44 Cells
Baseline
|
—
|
—
|
—
|
—
|
95.0 percentage of CD44 cells
|
—
|
—
|
|
Expression of Stem Cell Markers: CD44 Cells
End of mono therapy
|
—
|
—
|
—
|
—
|
87.5 percentage of CD44 cells
Standard Deviation 17.68
|
—
|
—
|
Adverse Events
Cantrixil 0.24 mg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cantrixil 0.6 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cantrixil 1.25 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cantrixil 2.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cantrixil 5 mg/kg
Serious events: 13 serious events
Other events: 13 other events
Deaths: 2 deaths
Cantrixil 10 mg/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Cantrixil 20 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cantrixil 0.24 mg/kg
n=2 participants at risk
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 participants at risk
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 participants at risk
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 participants at risk
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=17 participants at risk
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 participants at risk
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 participants at risk
Participants received Cantrixil 2- mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
17.6%
3/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Intestinal obstruction
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
17.6%
3/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
23.5%
4/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
11.8%
2/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
11.8%
2/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
Other adverse events
| Measure |
Cantrixil 0.24 mg/kg
n=2 participants at risk
Participants received Cantrixil 0.24 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 0.6 mg/kg
n=1 participants at risk
Participants received Cantrixil 0.6 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 1.25 mg/kg
n=1 participants at risk
Participants received Cantrixil 1.25 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 2.5 mg/kg
n=1 participants at risk
Participants received Cantrixil 2.5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 5 mg/kg
n=17 participants at risk
Participants received Cantrixil 5 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 10 mg/kg
n=2 participants at risk
Participants received Cantrixil 10 mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
Cantrixil 20 mg/kg
n=1 participants at risk
Participants received Cantrixil 2- mg/kg administered as a single intraperitoneal dose once a week for up to 24 weeks (8 x 3-week cycles).
In cycles 1-2 (6 weeks) they received Cantrixil only and in cycles 3-8 (18 weeks) they received Cantrixil in combination with a systemic chemotherapy.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
35.3%
6/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
2/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
41.2%
7/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
2/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
23.5%
4/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
2/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
1/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
General disorders
Fatigue
|
100.0%
2/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
23.5%
4/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
2/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
11.8%
2/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
100.0%
2/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
17.6%
3/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Abdominal discomfort
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
11.8%
2/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
5.9%
1/17 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
50.0%
1/2 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
0.00%
0/1 • Patients were followed from study entry up to 3 months after discontinuing therapy or until death or consent withdrawal, whichever occurred first, up to a maximum of 36 weeks.
Adverse events were classified according to the MedDRA, Version 20.0. Adverse events were categorised for severity according to the NCI CTCAE Version 4.03
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place