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

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