Status:
WITHDRAWN
Tivozanib + Gemcitabine in Metastatic RCC
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is a PHase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a spec...
Detailed Description
If you agree to participate in this study you will be asked to undergo some screening tests and procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of...
Eligibility Criteria
Inclusion
- Histologically confirmed renal cell carcinoma that is metastatic
- Failed at least one prior VEGF-targeted therapy
- Prior immunotherapy and mTOR inhibitors are allowed
- Evidence of unidimensionally measurable disease based on RECIST 1.1 criteria, with at least 1 measurable lesion
- Willing to use adequate contraceptive measures while on study and for 30 days after the lst dose of study drug
- For Segment 2, must have evidence of progressive disease
- For Segment 2, amenable to start Gemcitabine chemotherapy within 6 weeks of progression on Tivozanib
- For Segment 2, willing to undergo pre/post therapy biopsy of a metastatic lesion if safe and amenable
Exclusion
- Prior gemcitabine or tivozanib
- Anticipated need for major surgical procedure during the course of the study
- Pregnant or breastfeeding
- Known prior history of hypertensive crisis or hypertensive encephalopathy
- Primary central nervous system malignancies or leptomeningeal metastases
- Significant cardiac disease
- Subjects on warfarin
- Uncontrolled intercurrent illness
- Evidence of bleeding diathesis or known coagulopathy
- Serious, non-healing wound, ulcer or bone fracture
- Psychiatric illness/social situation that would limit compliance with study requirements
- Previous or concurrent malignancy requiring active systemic therapy, \< 4 years
- Inability to swallow pills, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of tivozanib, major resection of the stomach or small bowel, or gastric bypass procedure
- Ongoing use of strong CYP3A4 inducers
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01834183
Start Date
June 1 2013
End Date
June 1 2013
Last Update
June 19 2013
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215