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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tracon Pharmaceuticals Inc.
Study ID
NCT02664961
Phase
PHASE2
Status
Terminated

Conditions

  • Choriocarcinoma
  • Epithelioid Trophoblastic Tumor
  • Gestational Trophoblastic Neoplasia
  • Placental Site Trophoblastic Tumor

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • TRC105 — DRUG
    Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.
  • Bevacizumab — DRUG
    Bevacizumab will be dosed every two weeks.

Study Details

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.

Key Dates

First listed
Jan 27, 2016
Start date
Mar 31, 2016
Status verified
May 2019
Primary completion
Apr 30, 2018
Completion
Nov 30, 2018

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab [ Time Frame: 8 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Ohio State UniversityColumbusOhio43210-
UT SouthwesternDallasTexas75390-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAOhio State University· Columbus, OHUT Southwestern· Dallas, TX

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