A Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01306630|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : January 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Locally Advanced or Metastatic Breast or Colorectal Cancer||Drug: tivozanib (AV-951) and capecitabine (Xeloda®)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Open-Label, Dose-Escalating Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid Tumors|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
|tivozanib + capecitabine||
Drug: tivozanib (AV-951) and capecitabine (Xeloda®)
Tivozanib 1.0 mg or 1.5 mg oral once daily for 2 weeks followed by 1 week off. Capecitabine 825 mg/m2, 1000 mg/m2, or 1250 mg/m2, oral twice daily for 2 weeks followed by 1 week off. 1 cycle= 3 weeks. Cycles will be repeated in the absence of disease progression or unacceptable toxicity.
- To determine the safety, tolerability, and maximum tolerated dose of tivozanib when administered in combination with capecitabine (Xeloda®) to subjects with advanced solid tumors [ Time Frame: daily for 6 weeks ]Assessment of any dose-limiting toxcities
- Evaluate the pharmacokinetics of tivozanib, and capecitabine and its metabolites by measuring the serum plasma concentrations of tivozanib and capecitabine in the blood over time. [ Time Frame: Cycle 1 (Days 1, 2, 8, 14, and 15), Cycle 2 (Days 1 and 14), Cycles 3, 5, 7, and 9 (Day 1 only). ]PK parameters of tivozanib and capecitabine will be calculated from serum and plasma levels. These will be summarized descriptively and presented by visit and dose cohort. PK parameters will be calculated using non compartmental and/or compartmental models and PK parameters will be summarized and presented. The mean (± STDEM) concentration-time profiles of tivozanib, capecitabine, and their metabolite(s) will be presented for each dose.
- To evaluate the antineoplastic activity of tivozanib and capecitabine, when given together, to slow the growth of or shrink tumor as measured by CT/MRI imaging assessment and according to RECIST criteria. [ Time Frame: every 6 weeks ]Disease and response assessments will be determined using Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). Disease assessment is to include disease classification, tumor marker assessments, and diagnostic imaging / measurement of marker lesions. Computerized tomography (CT) will be considered the standard method for evaluating disease status. All subjects should have a CT scan (or MRI) of the head, chest, abdomen, and pelvis at baseline. The location and dimensions of "marker" lesions will be documented.
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): NCT01306630
|United States, Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, Florida|
|Fort Myers, Florida, United States, 33908|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Shefali Agarwal, M.D.||AVEO Pharmaceuticals, Inc.|