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

Primary Purpose

Choriocarcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TRC105

Bevacizumab

About this trial

This is an interventional treatment trial for Choriocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Insititue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRC105 and Bevacizumab

Arm Description

TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

Outcomes

Primary Outcome Measures

Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

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

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

Frequency and Severity of Adverse Events

Adverse event frequency and severity according to CTCAE version 4.0.

Full Information

NCT ID

NCT02396511

First Posted

March 5, 2015

Last Updated

May 17, 2019

Sponsor

Tracon Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02396511

Brief Title

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

Official Title

Patient Treatment Protocol of TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tracon Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choriocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRC105 and Bevacizumab

Arm Type

Experimental

Arm Description

TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion

Intervention Type

Biological

Intervention Name(s)

TRC105

Other Intervention Name(s)

Chimeric Antibody (TRC105) to CD105

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Bevacizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma

Description

Time Frame

Assessed every 8 weeks for up to 35 Months

Title

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

Description

Time Frame

Assessed every 8 weeks for up to 35 Months

Secondary Outcome Measure Information:

Title

Frequency and Severity of Adverse Events

Description

Adverse event frequency and severity according to CTCAE version 4.0.

Time Frame

Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Theuer, MD

Organizational Affiliation

Medical Monitor

Official's Role

Study Director

Facility Information:

Facility Name

Dana-Farber Cancer Insititue

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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