Trial intelligence / Profile preview

Bevacizumab Alone or in Combination With TRC105 for Advanced Renal Cell Cancer

NCT01727089Phase 2

Key facts

Status: Completed
Start: Nov 2012
Primary completion: Aug 2017
Countries: 3
Sponsor: National Cancer Institute
Modality: Monoclonal Antibodies

Drugs: carotuximab
Conditions: renal cell carcinoma (RCC)

Overview

Phase 2, randomised, open-label trial of carotuximab in renal cell carcinoma (RCC) (2 arms), sponsored by National Cancer Institute. Primary endpoint: Progression-free Survival at 24 weeks. Started Nov 2012; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Arm I (bevacizumab)
Bevacizumab IV on days 1 and 15 of every 28-day cycle.
Arm II (bevacizumab + TRC105)
Bevacizumab IV on days 1 and 15, and TRC105 IV on days 1, 8, 15, and 22 of every 28-day cycle.

Who it enrols

Patients with metastatic renal cell carcinoma who have received 1 to 4 prior systemic therapies, with adequate organ function and no prior treatment with bevacizumab or TRC105.

Endpoints

Primary

Progression-free Survival24 weeks

Secondary

Number of Participants With Grade 3 and Above Adverse Events Related to Treatmentup to 30 days post treatment
Overall Responseup to conclusion of treatment

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