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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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

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