Clinical trial · Interventional
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
NCT02396511CI-TRIAL-00039017completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choriocarcinoma | Choriocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| TRC105 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TRC105 and Bevacizumab
- description
- TRC105 weekly intravenous infusion bevacizumab every 2 weeks intravenous infusion
- interventionNames
- Biological: TRC105
- Biological: Bevacizumab
Primary outcomes (2)
- measure
- Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma
- timeFrame
- Assessed every 8 weeks for up to 35 Months
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.