Trial Outcomes & Findings for Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy (NCT NCT00424840)

Results Overview

Dose limiting toxicity at Level 1,2 and 3: Number of subjects who required dose delay/reduction in dose of bortezomib in the first cycle of treatment. DLT defined by any of the following during first cycle: (1) GR4 neutropenia or thrombocytopenia, (2) Greater than GR3 non-hematological toxicity except alopecia or inadequately treated nausea or vomiting or (3) neurosensory toxicity of GR2 with pain or any neurotoxicity greater than GR2.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

up to 21 days for each dosing cycle

Results posted on

2019-02-01

Participant Flow

Treatment q21 day cycle, maximum of 6 cycles. Patients with CR, PR, SD continued on single agent bevacizumab 15 mb/kg q 3 weeks.

Participant milestones

Participant milestones
Measure	Dose Level 1: 1.3 mg/m^2 Bortezomib Level 1 participants were given 1.3 mg/m\^2 Bortezomib with Carboplatin AUC6, bevacizumab 15 mg/kg	Dose Level II: 1.6 mg/m^2 Participants were given1.6 mg/m\^2 Bortezomib with Carboplatin AUC6, bevacizumab 15 mg/kg	Dose Level III: 1.8 mg/m^2 1.8 mg/m\^2 Bortezomib with Carboplatin AUC6, bevacizumab 15 mg/kg
Overall Study STARTED	3	4	5
Overall Study COMPLETED	3	4	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: Dose Level 1, 2 and 3 n=12 Participants 1.3 mg/m\^2 Bortezomib", "1.6 mg/m\^2 Bortezomib", and "1.8 mg/m\^2 Bortezomib In phase I, three dose levels of weekly bortezomib will be studied in conjunction with fixed dose carboplatin and bevacizumab on a 21 day cycle to define the maximum tolerated dose (MTD).
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 21 days for each dosing cycle

Dose limiting toxicity at Level 1,2 and 3: Number of subjects who required dose delay/reduction in dose of bortezomib in the first cycle of treatment. DLT defined by any of the following during first cycle: (1) GR4 neutropenia or thrombocytopenia, (2) Greater than GR3 non-hematological toxicity except alopecia or inadequately treated nausea or vomiting or (3) neurosensory toxicity of GR2 with pain or any neurotoxicity greater than GR2.

Outcome measures

Outcome measures
Measure	Phase I: Dose Level 1 n=3 Participants 1.3 mg/m\^2 Bortezomib	Phase 1 Dose Level II: n=4 Participants 1.6 mg/m\^2 Bortezomib	Phase I Dose Level III n=5 Participants 1.8 mg/m\^2 Bortezomib
Number of Subjects Who Require Dose Delay/Reduction in Dose of Bortezomibin the First Cycle	0 participants	0 participants	0 participants

Adverse Events

Phase I: Bevacizumab, Carboplatin, Bortezomib

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phase I: Bevacizumab, Carboplatin, Bortezomib n=12 participants at risk In phase I, three dose levels of weekly bortezomib will be studied in conjunction with fixed dose carboplatin and bevacizumab on a 21 day cycle to define the maximum tolerated dose (MTD). Bevacizumab will be administered first followed by carboplatin followed by bortezomib
Blood and lymphatic system disorders Anemia	25.0% 3/12 • Number of events 3 • 2 years From date of first dose to date of death or up to 2 years, whichever came first Adverse event data by separate arms not available
Gastrointestinal disorders Nausea	33.3% 4/12 • Number of events 4 • 2 years From date of first dose to date of death or up to 2 years, whichever came first Adverse event data by separate arms not available
Blood and lymphatic system disorders Hyponatremia	41.7% 5/12 • Number of events 5 • 2 years From date of first dose to date of death or up to 2 years, whichever came first Adverse event data by separate arms not available
Vascular disorders Peripheral Neuropathy	41.7% 5/12 • Number of events 5 • 2 years From date of first dose to date of death or up to 2 years, whichever came first Adverse event data by separate arms not available

Additional Information

Dr. William Walsh

University of Massachusetts Medical School

Phone: 508-334-5539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place