CompletedPhase 2

TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma

United States2 participantsStarted 2015-01

Plain-language summary

The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of two patients with metastatic and refractory choriocarcinoma.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willingness and ability to consent for self to participate in study
✓. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
✓. Measurable disease by RECIST 1.1 and elevated serum β-hCG
✓. Histologically proven choriocarcinoma that has progressed despite all described lines of chemotherapy for this condition

Exclusion criteria

✕. Prior treatment with TRC105
✕. Serious dose-limiting toxicity related to prior bevacizumab
✕. Current treatment on another therapeutic clinical trial
✕. Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg)
✕. Symptomatic pericardial or pleural effusions
✕. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
✕. Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)
✕. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy

What they're measuring

Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

Timeframe: Assessed every 8 weeks for up to 35 Months

Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG

Timeframe: Assessed every 8 weeks for up to 35 Months

Trial details

NCT IDNCT02396511

SponsorTracon Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12

Results submitted2019-04-16

View on ClinicalTrials.gov More Choriocarcinoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willingness and ability to consent for self to participate in study
✓. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
✓. Measurable disease by RECIST 1.1 and elevated serum β-hCG
✓. Histologically proven choriocarcinoma that has progressed despite all described lines of chemotherapy for this condition

Exclusion criteria

✕. Prior treatment with TRC105
✕. Serious dose-limiting toxicity related to prior bevacizumab
✕. Current treatment on another therapeutic clinical trial
✕. Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg)
✕. Symptomatic pericardial or pleural effusions
✕. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
✕. Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)
✕. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy

What they're measuring

Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

Timeframe: Assessed every 8 weeks for up to 35 Months

Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG

Timeframe: Assessed every 8 weeks for up to 35 Months