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

Completed · Phase 2

Conditions studied: Choriocarcinoma

In brief

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.

Key facts

Study ID

NCT02396511

Run by

Tracon Pharmaceuticals Inc.

People needed

2

Starts

2015-01-01

Expected to finish

2017-12-01

Last updated by the study team

2019-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days
• Known active viral or nonviral hepatitis
• Open wounds or unhealed fractures within 28 days of starting study treatment
• History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

Where it is running

• Dana-Farber Cancer Insititue — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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