Trial Outcomes & Findings for A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer (NCT NCT00653939)
NCT ID: NCT00653939
Last Updated: 2015-02-09
Results Overview
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Six 21-day cycles
Results posted on
2015-02-09
Participant Flow
Participant milestones
| Measure |
Arm 1: Chemotherapy+Bevacizumab
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Arm 1: Chemotherapy+Bevacizumab
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Disease Progression
|
2
|
3
|
|
Overall Study
Other
|
2
|
6
|
Baseline Characteristics
A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=29 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
61.0 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
62.2 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
31 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0 - Fully active
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1 - Restricted in physically strenuous activity
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Surgery Performed
Yes
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Surgery Performed
No
|
24 participants
n=99 Participants
|
27 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Prior Surgery Due to NSCLC
Yes
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Prior Surgery Due to NSCLC
No
|
26 participants
n=99 Participants
|
29 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Subject Given Radiation Therapy
Yes
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Subject Given Radiation Therapy
No
|
23 participants
n=99 Participants
|
27 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Subject Given Radiation Therapy
Information Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Prior Radiation Due to NSCLC
Yes
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Prior Radiation Due to NSCLC
No
|
25 participants
n=99 Participants
|
27 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Stage of Disease at Study Entry
IIIB
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Stage of Disease at Study Entry
IV
|
25 participants
n=99 Participants
|
29 participants
n=107 Participants
|
54 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Six 21-day cyclesPopulation: Intent-to-Treat
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.
Outcome measures
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=32 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Progression Free Survival (PFS) in the Intent-to-Treat Population
|
9.3 months
Interval 4.4 to 11.5
|
8.6 months
Interval 5.0 to 10.2
|
SECONDARY outcome
Timeframe: Six 21-day cyclesPopulation: Intent-to-Treat
Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.
Outcome measures
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=32 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Complete Response
|
0 participants
|
0 participants
|
|
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Partial Response
|
11 participants
|
18 participants
|
|
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Stable Disease
|
13 participants
|
8 participants
|
|
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Progressive Disease
|
3 participants
|
1 participants
|
|
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Unknown
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Until death or lost to follow-up, up to 12 months since randomizationPopulation: Intent-to-Treat
Outcome measures
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=32 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population
|
16.2 Months
Interval 9.9 to 17.7
|
13.6 Months
Interval 8.6 to 17.8
|
SECONDARY outcome
Timeframe: Days 1 (pretreatment) per 21-day Cycle (6 Cycles)Population: Safety Population
Outcome measures
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=29 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Glucose - Grade 3
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Glucose - Grade 4
|
1 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Creatinine - Grade 3
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Creatinine - Grade 4
|
1 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Calcium - Grade 3
|
3 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Calcium - Grade 4
|
1 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Magnesium - Grade 3
|
2 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Magnesium - Grade 4
|
2 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Phosphorus - Grade 3
|
0 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Phosphorus - Grade 4
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Potassium - Grade 3
|
5 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Potassium - Grade 4
|
1 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Sodium - Grade 3
|
5 participants
|
2 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Sodium - Grade 4
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
ALT - Grade 3
|
1 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
ALT - Grade 4
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
AST - Grade 3
|
0 participants
|
1 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
AST - Grade 4
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
ALP - Grade 3
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
ALP - Grade 4
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Total Bilirubin - Grade 3
|
0 participants
|
0 participants
|
|
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Total Bilirubin - Grade 4
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)Population: Safety Population
Outcome measures
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=29 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Hemoglobin - Grade 3
|
7 participants
|
0 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Hemoglobin - Grade 4
|
4 participants
|
1 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
White Blood Cell - Grade 3
|
14 participants
|
12 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
White Blood Cell - Grade 4
|
2 participants
|
1 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Absolute Neutrophils - Grade 3
|
4 participants
|
5 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Absolute Neutrophils - Grade 4
|
20 participants
|
20 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Platelets - Grade 3
|
3 participants
|
5 participants
|
|
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Platelets - Grade 4
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 (pretreatment) per 21-day Cycle (6 Cycles)Population: Safety Population
Outcome measures
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=29 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=31 Participants
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
INR - Grade 4
|
0 participants
|
0 participants
|
|
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
INR - Grade 3
|
2 participants
|
3 participants
|
|
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
PTT - Grade 3
|
3 participants
|
5 participants
|
|
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
PTT - Grade 4
|
0 participants
|
0 participants
|
Adverse Events
Arm 1: Chemotherapy+Bevacizumab
Serious events: 16 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm 2: Active Comparator+Fosbretabulin
Serious events: 16 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=29 participants at risk
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=31 participants at risk
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
1/29
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/29
|
6.5%
2/31
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29
|
3.2%
1/31
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29
|
0.00%
0/31
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.4%
1/29
|
0.00%
0/31
|
|
Cardiac disorders
Myocardial Infarction
|
3.4%
1/29
|
0.00%
0/31
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/29
|
6.5%
2/31
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
3.4%
1/29
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29
|
3.2%
1/31
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29
|
3.2%
1/31
|
|
General disorders
Asthenia
|
0.00%
0/29
|
3.2%
1/31
|
|
General disorders
Disease Progression
|
3.4%
1/29
|
0.00%
0/31
|
|
General disorders
Fatigue
|
3.4%
1/29
|
0.00%
0/31
|
|
General disorders
Infusion Site Thrombosis
|
0.00%
0/29
|
3.2%
1/31
|
|
General disorders
Non-cardiac Chest Pain
|
3.4%
1/29
|
0.00%
0/31
|
|
General disorders
Pyrexia
|
0.00%
0/29
|
3.2%
1/31
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.4%
1/29
|
0.00%
0/31
|
|
Infections and infestations
Arthritis Infective
|
3.4%
1/29
|
0.00%
0/31
|
|
Infections and infestations
Bronchitis
|
0.00%
0/29
|
3.2%
1/31
|
|
Infections and infestations
Lung Abscess
|
3.4%
1/29
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
6.9%
2/29
|
0.00%
0/31
|
|
Infections and infestations
Pseudomonal Bacteraemia
|
3.4%
1/29
|
0.00%
0/31
|
|
Infections and infestations
Sepsis
|
3.4%
1/29
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
3.4%
1/29
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
1/29
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/29
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.4%
1/29
|
0.00%
0/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
0.00%
0/29
|
6.5%
2/31
|
|
Nervous system disorders
Cerbral Infarction
|
3.4%
1/29
|
0.00%
0/31
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.4%
1/29
|
0.00%
0/31
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/29
|
3.2%
1/31
|
|
Psychiatric disorders
Delirium
|
6.9%
2/29
|
0.00%
0/31
|
|
Psychiatric disorders
Mental Status Changes
|
3.4%
1/29
|
0.00%
0/31
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/29
|
3.2%
1/31
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/29
|
3.2%
1/31
|
|
Renal and urinary disorders
Urinary Retention
|
3.4%
1/29
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.4%
1/29
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/29
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Epixtaxis
|
3.4%
1/29
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
1/29
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/29
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.4%
1/29
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Repiratory Failure
|
0.00%
0/29
|
3.2%
1/31
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/29
|
3.2%
1/31
|
|
Vascular disorders
Hypertension
|
3.4%
1/29
|
0.00%
0/31
|
|
Vascular disorders
Hypotension
|
0.00%
0/29
|
3.2%
1/31
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/29
|
3.2%
1/31
|
Other adverse events
| Measure |
Arm 1: Chemotherapy+Bevacizumab
n=29 participants at risk
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
Arm 2: Active Comparator+Fosbretabulin
n=31 participants at risk
Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.
Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
48.3%
14/29
|
80.6%
25/31
|
|
Blood and lymphatic system disorders
Anaemia
|
69.0%
20/29
|
41.9%
13/31
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
62.1%
18/29
|
41.9%
13/31
|
|
Blood and lymphatic system disorders
Leukopenia
|
24.1%
7/29
|
45.2%
14/31
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.3%
3/29
|
3.2%
1/31
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/29
|
9.7%
3/31
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/29
|
6.5%
2/31
|
|
Gastrointestinal disorders
Nausea
|
69.0%
20/29
|
41.9%
13/31
|
|
Gastrointestinal disorders
Diarrhoea
|
58.6%
17/29
|
35.5%
11/31
|
|
Gastrointestinal disorders
Constipation
|
37.9%
11/29
|
35.5%
11/31
|
|
Gastrointestinal disorders
Vomiting
|
37.9%
11/29
|
22.6%
7/31
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.2%
5/29
|
16.1%
5/31
|
|
Gastrointestinal disorders
Stomatitis
|
10.3%
3/29
|
16.1%
5/31
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
17.2%
5/29
|
3.2%
1/31
|
|
Gastrointestinal disorders
Gingival Bleeding
|
10.3%
3/29
|
6.5%
2/31
|
|
Gastrointestinal disorders
Toothache
|
13.8%
4/29
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/29
|
9.7%
3/31
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29
|
6.5%
2/31
|
|
Gastrointestinal disorders
Oral Pain
|
3.4%
1/29
|
6.5%
2/31
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/29
|
6.5%
2/31
|
|
Gastrointestinal disorders
Gastritis
|
6.9%
2/29
|
0.00%
0/31
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.9%
2/29
|
0.00%
0/31
|
|
General disorders
Fatigue
|
86.2%
25/29
|
58.1%
18/31
|
|
General disorders
Pyrexia
|
34.5%
10/29
|
19.4%
6/31
|
|
General disorders
Oedema peripheral
|
20.7%
6/29
|
25.8%
8/31
|
|
General disorders
Asthenia
|
20.7%
6/29
|
12.9%
4/31
|
|
General disorders
Chest Discomfort
|
6.9%
2/29
|
16.1%
5/31
|
|
General disorders
Chills
|
10.3%
3/29
|
6.5%
2/31
|
|
General disorders
Gait Disturbance
|
6.9%
2/29
|
9.7%
3/31
|
|
General disorders
Non-cardiac Chest Pain
|
6.9%
2/29
|
9.7%
3/31
|
|
General disorders
Mucosal Inflammation
|
3.4%
1/29
|
9.7%
3/31
|
|
General disorders
Pain
|
10.3%
3/29
|
3.2%
1/31
|
|
General disorders
Chest Pain
|
3.4%
1/29
|
6.5%
2/31
|
|
General disorders
Infusion Site Pain
|
0.00%
0/29
|
9.7%
3/31
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/29
|
6.5%
2/31
|
|
Nervous system disorders
Neuropathy
|
65.5%
19/29
|
48.4%
15/31
|
|
Nervous system disorders
Headache
|
41.4%
12/29
|
12.9%
4/31
|
|
Nervous system disorders
Dizziness
|
31.0%
9/29
|
9.7%
3/31
|
|
Nervous system disorders
Hypoaesthesia
|
10.3%
3/29
|
19.4%
6/31
|
|
Nervous system disorders
Dysgeusia
|
10.3%
3/29
|
9.7%
3/31
|
|
Nervous system disorders
Burning Sensation
|
3.4%
1/29
|
9.7%
3/31
|
|
Nervous system disorders
Syncope
|
6.9%
2/29
|
6.5%
2/31
|
|
Nervous system disorders
Amnesia
|
0.00%
0/29
|
6.5%
2/31
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/29
|
6.5%
2/31
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/29
|
6.5%
2/31
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/29
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
34.5%
10/29
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
Anorexia
|
31.0%
9/29
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.2%
5/29
|
19.4%
6/31
|
|
Metabolism and nutrition disorders
Dehydration
|
27.6%
8/29
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.2%
5/29
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
2/29
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
2/29
|
12.9%
4/31
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.9%
2/29
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
55.2%
16/29
|
35.5%
11/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
37.9%
11/29
|
29.0%
9/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.1%
7/29
|
25.8%
8/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolarygeal Pain
|
31.0%
9/29
|
12.9%
4/31
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
17.2%
5/29
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.9%
2/29
|
16.1%
5/31
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.3%
3/29
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
6.9%
2/29
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.8%
4/29
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.4%
1/29
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.9%
2/29
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
10.3%
3/29
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.9%
2/29
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/29
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/29
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
34.5%
10/29
|
22.6%
7/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.1%
7/29
|
22.6%
7/31
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.8%
4/29
|
29.0%
9/31
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
20.7%
6/29
|
19.4%
6/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
20.7%
6/29
|
16.1%
5/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.2%
5/29
|
19.4%
6/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
13.8%
4/29
|
12.9%
4/31
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
10.3%
3/29
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
6.9%
2/29
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.4%
1/29
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.9%
2/29
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/29
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/29
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.2%
16/29
|
41.9%
13/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.1%
7/29
|
22.6%
7/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29
|
12.9%
4/31
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.3%
3/29
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.9%
2/29
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
6.9%
2/29
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
0.00%
0/29
|
6.5%
2/31
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
13.8%
4/29
|
16.1%
5/31
|
|
Infections and infestations
Urinary Tract Infection
|
20.7%
6/29
|
9.7%
3/31
|
|
Infections and infestations
Bronchitis
|
13.8%
4/29
|
3.2%
1/31
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
4/29
|
3.2%
1/31
|
|
Infections and infestations
Pneumonia
|
13.8%
4/29
|
0.00%
0/31
|
|
Infections and infestations
Catheter Site Infection
|
6.9%
2/29
|
3.2%
1/31
|
|
Infections and infestations
Cellulitis
|
6.9%
2/29
|
3.2%
1/31
|
|
Infections and infestations
Fungal Infection
|
10.3%
3/29
|
0.00%
0/31
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29
|
6.5%
2/31
|
|
Infections and infestations
Oral Candidiasis
|
6.9%
2/29
|
0.00%
0/31
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/29
|
6.5%
2/31
|
|
Vascular disorders
Hypertension
|
44.8%
13/29
|
54.8%
17/31
|
|
Vascular disorders
Hypotension
|
24.1%
7/29
|
3.2%
1/31
|
|
Vascular disorders
Flushing
|
3.4%
1/29
|
12.9%
4/31
|
|
Vascular disorders
Orthostatic Hypotension
|
17.2%
5/29
|
0.00%
0/31
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/29
|
9.7%
3/31
|
|
Investigations
Weight Decreased
|
27.6%
8/29
|
9.7%
3/31
|
|
Investigations
Alanine Aminotransferase Increased
|
10.3%
3/29
|
3.2%
1/31
|
|
Investigations
Breath Sounds Abnormal
|
3.4%
1/29
|
9.7%
3/31
|
|
Investigations
Gamma-glutamyltransferase Increased
|
6.9%
2/29
|
6.5%
2/31
|
|
Investigations
Blood Chloride Decreased
|
0.00%
0/29
|
6.5%
2/31
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/29
|
6.5%
2/31
|
|
Investigations
Blood Urea Increased
|
6.9%
2/29
|
0.00%
0/31
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.00%
0/29
|
6.5%
2/31
|
|
Investigations
Oxygen Saturation Decreased
|
6.9%
2/29
|
0.00%
0/31
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/29
|
6.5%
2/31
|
|
Psychiatric disorders
Insomnia
|
17.2%
5/29
|
22.6%
7/31
|
|
Psychiatric disorders
Depression
|
13.8%
4/29
|
19.4%
6/31
|
|
Psychiatric disorders
Anxiety
|
10.3%
3/29
|
6.5%
2/31
|
|
Psychiatric disorders
Confusional State
|
6.9%
2/29
|
3.2%
1/31
|
|
Psychiatric disorders
Delirium
|
6.9%
2/29
|
0.00%
0/31
|
|
Cardiac disorders
Tachycardia
|
10.3%
3/29
|
25.8%
8/31
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/29
|
12.9%
4/31
|
|
Cardiac disorders
Angina Pectoris
|
6.9%
2/29
|
3.2%
1/31
|
|
Cardiac disorders
Coronary Artery Disease
|
3.4%
1/29
|
6.5%
2/31
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/29
|
9.7%
3/31
|
|
Cardiac disorders
Cardiac Failure Congestive
|
6.9%
2/29
|
0.00%
0/31
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/29
|
6.5%
2/31
|
|
Renal and urinary disorders
Proteinuria
|
17.2%
5/29
|
9.7%
3/31
|
|
Renal and urinary disorders
Haematuria
|
6.9%
2/29
|
3.2%
1/31
|
|
Renal and urinary disorders
Urinary Retention
|
6.9%
2/29
|
3.2%
1/31
|
|
Eye disorders
Vision Blurred
|
6.9%
2/29
|
6.5%
2/31
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
2/29
|
3.2%
1/31
|
|
Ear and labyrinth disorders
Ear Pain
|
6.9%
2/29
|
6.5%
2/31
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/29
|
6.5%
2/31
|
|
Immune system disorders
Drug Hypersensitivity
|
3.4%
1/29
|
6.5%
2/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
0.00%
0/29
|
6.5%
2/31
|
|
Reproductive system and breast disorders
Prostatitis
|
6.9%
2/29
|
0.00%
0/31
|
|
Endocrine disorders
Endocrine Disorders
|
6.9%
2/29
|
3.2%
1/31
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
3.4%
1/29
|
6.5%
2/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place