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

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

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.

Study Overview

• Status: Completed
• Conditions: Choriocarcinoma
• Intervention / Treatment: Biological: TRC105; Biological: Bevacizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Insititue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRC105 and Bevacizumab; TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion	Biological: TRC105; weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops; Other Names: Chimeric Antibody (TRC105) to CD105; Biological: Bevacizumab; Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	Assessed every 8 weeks for up to 35 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tracon Pharmaceuticals Inc.
• Investigators: Study Director: Charles Theuer, MD, Medical Monitor

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Choriocarcinoma; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 105CC201 & 105CC201B