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

Phase 2

Completed

Conditions: Choriocarcinoma

Interventions: Biological: TRC105
Biological: Bevacizumab

Registration Number: NCT02396511

Lead Sponsor: Tracon Pharmaceuticals Inc.

Brief 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.

Detailed Description: Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 is a monoclonal antibody to CD105, an angiogenic target highly expressed on the tumor vessels and the tumor cells in choriocarcinoma. Together, these antibodies may be efficacious in metastatic and refractory choriocarcinoma, a tumor type that is highly vascular and expresses endoglin. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2

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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRC105 and Bevacizumab	Bevacizumab	TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion
TRC105 and Bevacizumab	TRC105	TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

Primary Outcome Measures

Name	Time	Method
Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma	Assessed every 8 weeks for up to 35 Months	Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma determined according to RECIST 1.1 including measurement of serum β- hCG. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. A 5 mm absolute increase is also required to guard against over calling PD when the total sum is very small.
Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG	Assessed every 8 weeks for up to 35 Months	To determine the Objective Response Rate of two patients with metastatic and refractory choriocarcinoma by RECIST 1.1 including measurement of serum β- hCG. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) categorizes response as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Name	Time	Method
Frequency and Severity of Adverse Events	Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.	Adverse event frequency and severity according to CTCAE version 4.0.