Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma

Phase 1/2 Terminated 173 enrolled Tracon Pharmaceuticals Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI

Timeline

Start: 2013-03-08
Primary completion: 2018-12-21
Completion: 2019-06-12

Outcome

Outcome not reported

Stopped: “The study did not meet endpoint.”

Publications

Choueiri TK, Michaelson MD, Posadas EM, Sonpavde GP, McDermott DF, Nixon AB, Liu Y, Yuan Z, Seon BK, Walsh M, Jivani MA, Adams BJ, Theuer CP. An Open Label Phase Ib Dose Escalation Study of TRC105 (Anti-Endoglin Antibody) with Axitinib in Patients with Metastatic Renal Cell Carcinoma. Oncologist. 2019 Feb;24(2):202-210. doi: 10.1634/theoncologist.2018-0299. Epub 2018 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Axitinib	Small molecule	5 mg	Oral
Subject	Carotuximab	Monoclonal antibody	10 mg/kg	—