Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)
|ClinicalTrials.gov Identifier: NCT02664961|
Recruitment Status : Terminated (Rare tumor type, patients eligible via expanded access.)
First Posted : January 27, 2016
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gestational Trophoblastic Neoplasia Choriocarcinoma Placental Site Trophoblastic Tumor Epithelioid Trophoblastic Tumor||Drug: TRC105 Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2A Study of TRC105 (With Option to Add Bevacizumab) in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||November 2018|
Experimental: TRC105 and/or bevacizumab
All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.
Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.
Other Name: Chimeric Antibody (TRC105) to CD105
Bevacizumab will be dosed every two weeks.
Other Name: Avastin
- 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 ]Serum hCG and RECIST version 1.1
- Preliminary evidence of antitumor activity of TRC105 will be assessed by Progression-Free Survival (PFS). [ Time Frame: 20 months ]Serum hCG and RECIST version 1.1
- Preliminary evidence of antitumor activity of single agent bevacizumab will be assessed by Overall Response Rate (ORR). [ Time Frame: 20 months ]Serum hCG and RECIST version 1.1
- Changes in circulating angiogenic biomarkers following treatment with TRC105 and bevacizumab. [ Time Frame: 20 months ]Angiogenic protein biomarker data for each patient who received at least one dose of study drug compared based on treatment with TRC105, bevacizumab and while receiving both agents.
- Maximum plasma concentration (Cmax) of TRC105. [ Time Frame: 20 months ]Serum TRC105 and bevacizumab concentrations will be measured using validated methods and assessed for potential correlations with response, PFS, survival, adverse events, baseline characteristics and immunogenicity using descriptive statistics and models as appropriate.
- TRC105 immunogenicity as assessed by Anti-Product Antibody (APA). [ Time Frame: 20 months ]Anti-Product Antibody (APA) concentrations will be measured using validated ELISA methods at the time points specified in the protocol. APA concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
- Frequency and severity of adverse events [ Time Frame: 20 months ]Assessed by NCI CTCAE (Version 4.03)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664961
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Study Director:||Charles Theuer, MD, PhD||Tracon Pharmaceuticals Inc.|