Clinical Trial: Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2A Study of TRC105 (With Option to Add Bevacizumab) in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

Brief Summary: The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT)). Up to 30 patients will be treated.

Detailed Summary: TRC105 is a monoclonal antibody that binds to endoglin, an angiogenic target highly expressed on the tumor vessels and tumor cells in gestational trophoblastic neoplasia (GTN). Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 has been well tolerated as a single agent and when combined with bevacizumab. These antibodies may be efficacious in refractory GTN, a tumor type that is highly vascular and has been shown to densely express endoglin.
Sponsor: Tracon Pharmaceuticals Inc.

Current Primary Outcome: Preliminary Evidence of Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed by Overall Response Rate (ORR). [ Time Frame: 20 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Preliminary evidence of antitumor activity of TRC105 will be assessed by Progression-Free Survival (PFS). [ Time Frame: 20 months ]
  • Preliminary evidence of antitumor activity of single agent bevacizumab will be assessed by Overall Response Rate (ORR). [ Time Frame: 20 months ]
  • Changes in circulating angiogenic biomarkers following treatment with TRC105 and bevacizumab. [ Time Frame: 20 months ]
  • Maximum plasma concentration (Cmax) of TRC105. [ Time Frame: 20 months ]
  • TRC105 immunogenicity as assessed by Anti-Product Antibody (APA). [ Time Frame: 20 months ]
  • Frequency and severity of adverse events as assessed by NCI CTCAE (Version 4.03). [ Time Frame: 20 months ]
  • Maximum plasma concentration (Cmax) of bevacizumab. [ Time Frame: 20 months ]


Original Secondary Outcome: Same as current

Information By: Tracon Pharmaceuticals Inc.

Dates:
Date Received: January 20, 2016
Date Started: March 2016
Date Completion: August 2017
Last Updated: November 1, 2016
Last Verified: November 2016