Spots Global Cancer Trial Database for Study of Tivozanib (AV-951) Plus FOLFOX6 in Subjects With Advanced Colorectal Cancer and Other Gastrointestinal Cancers
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Trial Identification
Brief Title: Study of Tivozanib (AV-951) Plus FOLFOX6 in Subjects With Advanced Colorectal Cancer and Other Gastrointestinal Cancers
Official Title: A Phase 1b, Open-Label, Dose-Escalation Study of Tivozanib (AV-951) Plus FOLFOX6 in Subjects With Advanced Colorectal Cancer and Other Gastrointestinal Cancers
Study ID: NCT00660153
Interventions
Study Description
Brief Summary: The FOLFOX6 regimen is a standard chemotherapy regimen for the treatment of patients with colorectal cancer and other gastrointestinal cancers. Tivozanib (AV-951) is a targeted anti-angiogenesis agent that has demonstrated acceptable tolerability in a phase I clinical trial. This study is designed to test the hypothesis that tivozanib (AV-951) can be combined with standard FOLFOX6 chemotherapy for the treatment of patients with colorectal and other gastrointestinal cancers. The purpose of this study is to determine the maximum dose of tivozanib (AV-951) that can be safely combined with FOLFOX6 chemotherapy, and to evaluate the safety profile, tolerability, and pharmacokinetics of this combination.
Detailed Description: This is a Phase 1b, open-label, study design that will examine safety, tolerability, and maximum tolerated dose of tivozanib (AV-951) and FOLFOX6 in advanced colorectal cancer and other gastrointestinal cancers. In the 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 standard doses of FOLFOX6 chemotherapy every 2 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Medical Center Groningen; Internal Medicine, Department of Medical Oncology, Groningen, , Netherlands
Erasmus Medical Center; Department of Medical Oncology, Rotterdam, , Netherlands
Contact Details
Name: Ferry Eskens, MD, PhD
Affiliation: Erasmus Medical Center; Department of Medical Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: E.G.E de Vries, Prof, MD
Affiliation: University Medical Center Groningen
Role: PRINCIPAL_INVESTIGATOR
Name: Jaroslow Jac, MD
Affiliation: AVEO Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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