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Trial Outcomes & Findings for A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer. (NCT NCT00432562)

NCT ID: NCT00432562

Last Updated: 2012-02-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

0-144 hours post dose

Results posted on

2012-02-23

Participant Flow

STUDIED PERIOD: First Patient Enrolled: 22 March 2007 Last Patient Completed: 02 November 2007 Study patients were enrolled at seven study sites in Argentina.

Pre-screening data was not collected for this study

Participant milestones

Participant milestones
Measure
ANX-530/Navelbine
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
Navelbine/ANX-530
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
Overall Study
STARTED
16
15
Overall Study
COMPLETED
13
15
Overall Study
NOT COMPLETED
3
0

Reasons for withdrawal

Reasons for withdrawal
Measure
ANX-530/Navelbine
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
Navelbine/ANX-530
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
Overall Study
Death
3
0

Baseline Characteristics

A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ANX-530/Navelbine
n=16 Participants
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
Navelbine/ANX-530
n=15 Participants
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
Total
n=31 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=39 Participants
10 Participants
n=41 Participants
21 Participants
n=35 Participants
Age, Categorical
>=65 years
5 Participants
n=39 Participants
5 Participants
n=41 Participants
10 Participants
n=35 Participants
Age Continuous
62.2 years
STANDARD_DEVIATION 12.77 • n=39 Participants
58.0 years
STANDARD_DEVIATION 13.34 • n=41 Participants
60.2 years
STANDARD_DEVIATION 13.00 • n=35 Participants
Sex: Female, Male
Female
14 Participants
n=39 Participants
12 Participants
n=41 Participants
26 Participants
n=35 Participants
Sex: Female, Male
Male
2 Participants
n=39 Participants
3 Participants
n=41 Participants
5 Participants
n=35 Participants
Region of Enrollment
Argentina
16 participants
n=39 Participants
15 participants
n=41 Participants
31 participants
n=35 Participants

PRIMARY outcome

Timeframe: 0-144 hours post dose

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=31 Participants
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0.35 hours
Standard Deviation 0.13
0.34 hours
Standard Deviation 0.08

PRIMARY outcome

Timeframe: 0-144 hours post-dose

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=31 Participants
Maximum Observed Plasma Concentration (Cmax)
227 ng/mL
Standard Deviation 108
223 ng/mL
Standard Deviation 125

PRIMARY outcome

Timeframe: 0-144 hours post-dose

Determined Using the Linear Trapezoidal Rule

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=31 Participants
Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
757.8 hr*ng/mL
Standard Deviation 363.7
716.1 hr*ng/mL
Standard Deviation 272.6

PRIMARY outcome

Timeframe: 0-144 hours post-dose

AUCinf = AUClast + (Clast/lamda z)

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=30 Participants
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
810.1 hr*ng/mL
Standard Deviation 400.9
718.5 hr*ng/mL
Standard Deviation 223.5

PRIMARY outcome

Timeframe: 0-144 hours post-dose

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=30 Participants
Percentage of AUCinf Based on Extrapolation (AUCextrap)
6.23 % of participants
Standard Deviation 2.54
4.72 % of participants
Standard Deviation 3.11

PRIMARY outcome

Timeframe: 0-144 hours post-dose

Estimated via linear regression of the time versus log concentration

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=30 Participants
Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
0.0160 hr-1
Standard Deviation 0.0044
0.0187 hr-1
Standard Deviation 0.0062

PRIMARY outcome

Timeframe: 0-144 hours post-dose

t1/2 = \[ln(2)/λ z\]

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=30 Participants
Observed Terminal Elimination Half-Life (t1/2)
46.50 hours
Standard Deviation 12.43
40.48 hours
Standard Deviation 13.50

PRIMARY outcome

Timeframe: 0-144 hours post-dose

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=31 Participants
Time of Last Measurable Concentration (Tlast)
141.83 hours
Standard Deviation 12.93
141.79 hours
Standard Deviation 12.92

PRIMARY outcome

Timeframe: 0-144 hours post-dose

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=31 Participants
Last Quantifiable Drug Concentration (Clast)
0.819 ng/mL
Standard Deviation 0.834
0.824 ng/mL
Standard Deviation 1.31

PRIMARY outcome

Timeframe: 0-144 hours post-dose

MRT = (AUMCinf)/(AUCinf)

Outcome measures

Outcome measures
Measure
ANX-530
n=31 Participants
Navelbine
n=30 Participants
Mean Residence Time (MRTinf)
35.39 hours
Standard Deviation 7.90
31.31 hours
Standard Deviation 10.06

Adverse Events

ANX-530/Navelbine

Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths

Navelbine/ANX-530

Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ANX-530/Navelbine
n=31 participants at risk；n=16 participants at risk
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
Navelbine/ANX-530
n=31 participants at risk；n=15 participants at risk
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
Blood and lymphatic system disorders
ANAEMIA
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Infections and infestations
FEBRILE INFECTION
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
6.7%
1/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Infections and infestations
GENITAL INFECTION FEMALE
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
LEUKOPENIA
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
NEUTROPENIA
18.8%
3/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Infections and infestations
PNEUMONIA
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Nervous system disorders
STUPOR
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Nervous system disorders
COMA
6.2%
1/16 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/15 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.

Other adverse events

Other adverse events
Measure
ANX-530/Navelbine
n=31 participants at risk；n=16 participants at risk
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
Navelbine/ANX-530
n=31 participants at risk；n=15 participants at risk
Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
Gastrointestinal disorders
ABDOMINAL PAIN
12.9%
4/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
ANAEMIA
9.7%
3/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
9.7%
3/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
General disorders
ASTHENIA
9.7%
3/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
6.5%
2/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
0.00%
0/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
6.5%
2/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Gastrointestinal disorders
CONSTIPATION
16.1%
5/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
16.1%
5/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
General disorders
INFUSION SITE PHLEBITIS
3.2%
1/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
22.6%
7/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
LEUKOPENIA
19.4%
6/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
9.7%
3/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
6.5%
2/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
0.00%
0/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Gastrointestinal disorders
NAUSEA
16.1%
5/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
12.9%
4/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
NEUTROPENIA
38.7%
12/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
22.6%
7/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Skin and subcutaneous tissue disorders
RASH
9.7%
3/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
3.2%
1/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
3.2%
1/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
6.5%
2/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
Gastrointestinal disorders
VOMITING
6.5%
2/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.
3.2%
1/31 • AEs and their treatment were documented from the time of the first dose of study medication until 30 days after the last dose. Mild, moderate and severe AEs not related to study treatment were followed for approx 30 days after the last study drug dose.
Events that were serious, life threatening or related to study treatment were followed until resolution, downgrading of an SAE to non-serious, subject death, start of new cancer therapy or re-assessment of the event's relationship to study medication.

Additional Information

Chief Executive Officer

Adventrx Pharmaceuticals

Phone: 858-768-6325

Results disclosure agreements

  • Principal investigator is a sponsor employee Any publication of data related to the Study, including publication in special medical magazines, or the disclosure at medical congresses shall be previously authorized in writing by the Sponsor, whereby the Principal Investigator should present the material with an anticipation of not less than 60 days as from the publication or medical congress. The Sponsor decides upon the authorship of any publication related to the Study.
  • Publication restrictions are in place

Restriction type: OTHER