Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

March 4, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
CholangiocarcinomaBile Duct NeoplasmBiliary Tract Malignancy
Interventions
DRUG

Tivozanib

Oral tivozanib taken daily for Days 1-21 continuously (of each 28-day cycle) followed with 7 days off medication (except for patients in DL-1, with dosing every other day of the 28-day cycle). Phase I: The starting dose (DL1) is 0.89 mg taken once a day continuously for Days 1-21 with 1 week off medication (except for those patients assigned to DL-1, where tivozanib should be taken every other day, around 48 hours apart in 28-day cycle). Patients may escalate to 1.34 mg taken once a day (DL2) continuously for Days 1-21 with 1 week off medication for their second cycle if there are no dose-limiting toxicities. Phase II: Tivozanib dose level will be at the recommended Phase II dose (RP2D) established in Phase I.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH