Clinical trial NCT02396511: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choriocarcinoma
Lead sponsor: Tracon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma
timeFrame: Assessed every 8 weeks for up to 35 Months
measure: Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG
timeFrame: Assessed every 8 weeks for up to 35 Months
Secondary outcomes:
measure: Frequency and Severity of Adverse Events
timeFrame: Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Insititue
state: Massachusetts
Study officials:
affiliation: Medical Monitor
name: Charles Theuer, MD
role: STUDY_DIRECTOR
References: