A Phase 1b/2a, Open-Label, Multi-Center Study of Tivozanib (AV-951) in Combination With Paclitaxel in Subjects With Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00717340|
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : June 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: tivozanib (AV-951) + paclitaxel||Phase 1|
This is a standard Phase 1b and 2a, multi-center, study design that will examine the safety, tolerability, maximum tolerated dose, and overall response rate of tivozanib (AV-951) and paclitaxel in a breast cancer.
In the Phase 1b study, only the doses of tivozanib (AV-951) will be escalated from 0.5 mg/day to 1.5 mg /day. All subjects will receive doses of weekly paclitaxel chemotherapy.
The Phase 2a study portion of the study was not conducted.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2a, Open-Label, Multi-Center Study of Tivozanib (AV-951) in Combination With Paclitaxel in Subjects With Advanced or Metastatic Breast Cancer|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2011|
|Experimental: tivozanib (AV-951) + paclitaxel||
Drug: tivozanib (AV-951) + paclitaxel
Subjects in the Phase 1b study will receive 1 dose of tivozanib (AV-951) on Day -5 (± 2 days) for PK sampling prior to Cycle 1 only.
Thereafter in the Phase 1b and 2a study, subjects will receive tivozanib (AV-951) once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment (1 cycle = 4 weeks). On days when paclitaxel and tivozanib (AV-951) are co-administered, AV-951 will be administered immediately following the end of the paclitaxel infusion.
Paclitaxel: Phase 1b study and Phase 2a study:
All subjects will receive IV paclitaxel 90 mg/m2, administered over 1 hour once a week for 3 weeks, followed by 1 week off (1 cycle = 4 weeks).
- To determine the safety, tolerability, and maximum tolerated dose (MTD) of tivozanib (AV-951) when administered in combination with paclitaxel (Phase 1b study) [ Time Frame: 4 weeks (1 Cycle) ]
- To determine the overall response rate of tivozanib (AV-951) in combination with paclitaxel as a first-line chemotherapy for metastatic breast cancer (Phase 2a study) [ Time Frame: 8 weeks (2 Cycles) ]
- To characterize the pharmacokinetic (PK) profile of tivozanib (AV-951) and paclitaxel when administered in combination (Phase 1b study) [ Time Frame: 8 weeks (2 cycles) ]
- To evaluate the antineoplastic activity of tivozanib (AV-951) and paclitaxel when administered in combination (Phase 1b study) [ Time Frame: 8 weeks (2 Cycles) ]
- To perform an exploratory study in a subset of subjects to evaluate (Phase 1b study): -Changes in FMD during treatment with tivozanib (AV-951) -The relationship between hypertension during tivozanib (AV-951) therapy, FMD and plasma NT levels [ Time Frame: 12 weeks (3 Cycles) ]
- To determine the duration of complete and partial responses and time to disease progression (Phase 2a study) [ Time Frame: Not applicable to determine weeks ]
- To determine the safety and tolerability of tivozanib (AV-951) when administered in combination with paclitaxel (Phase 2a study) [ Time Frame: 4 weeks (1 cycle) ]
- To evaluate the effect of tivozanib (AV-951) and paclitaxel on global and targeted gene expression patterns (Phase 2a study) [ Time Frame: 8 weeks (2 Cycles) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717340
|United States, Massachusetts|
|Dana Farber Cancer Institute, Inc.|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Essen, Germany, D-45147|
|Study Director:||Joshua Zhang, M.D.||AVEO Pharmaceuticals, Inc.|
|Principal Investigator:||Erica Mayer, M.D.||Dana Farber Cancer Institute, Inc.|
|Principal Investigator:||Max E. Scheulen, M.D.||Universitaetsklinikum Essen, Germany|
|Principal Investigator:||Maura Dickler, M.D.||Memorial Sloan Kettering Cancer Center|