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Phase 2 N=2 Treatment

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

Choriocarcinoma

Enrolled (actual)
2
Serious AEs
100.0%
Results posted
Jun 2019
Primary outcome: Primary: Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma — 18 Months

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
TRC105 (Biological); Bevacizumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tracon Pharmaceuticals Inc.
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma
18
PRIMARY
Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG
1; 1
SECONDARY
Frequency and Severity of Adverse Events
4; 3

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02396511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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