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

NCT ID: NCT02396511

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Choriocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRC105 and Bevacizumab

TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

Group Type: EXPERIMENTAL

TRC105

Intervention Type: BIOLOGICAL

weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops

Bevacizumab

Intervention Type: BIOLOGICAL

Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops

Interventions

TRC105

weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops

Intervention Type: BIOLOGICAL

Bevacizumab

Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops

Intervention Type: BIOLOGICAL

Other Intervention Names

Chimeric Antibody (TRC105) to CD105

Eligibility Criteria

Inclusion Criteria

1. Willingness and ability to consent for self to participate in study

2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

3. Measurable disease by RECIST 1.1 and elevated serum β-hCG

4. Histologically proven choriocarcinoma that has progressed despite all described lines of chemotherapy for this condition

Exclusion Criteria

1. Prior treatment with TRC105

2. Serious dose-limiting toxicity related to prior bevacizumab

3. Current treatment on another therapeutic clinical trial

4. 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)

5. Symptomatic pericardial or pleural effusions

6. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks

7. Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)

8. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy

9. Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days

10. Known active viral or nonviral hepatitis

11. Open wounds or unhealed fractures within 28 days of starting study treatment

12. 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

13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness

14. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tracon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Theuer, MD

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Dana-Farber Cancer Insititue

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

105CC201 & 105CC201B

Identifier Type: -

Identifier Source: org_study_id