Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (… (NCT02664961) | Clinical Trial Compass
TerminatedPhase 2
Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)
Stopped: Rare tumor type, patients eligible via expanded access.
United States3 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range16 Years – 99 Years
SexFEMALE
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Inclusion criteria
✓. Willingness and ability to consent for self to participate in study
✓. Willingness and ability to comply with study procedures
✓. Elevated serum hCG (in cases of choriocarcinoma); elevated hCG or measurable disease (in cases of PSTT or ETT)
✓. Histologically proven trophoblastic neoplasia, or clinically demonstrated trophoblastic neoplasia that has progressed following treatment with at least one chemotherapy regimen that included 2 or more chemotherapy agents.
✓. Age of 16 years or older
✓. ECOG performance status ≤ 1
✓. Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline
✓. Adequate organ function
Exclusion criteria
✕. Male
✕. Prior treatment with TRC105
What they're measuring
1
Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab