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Trial record 1 of 1 for:    NCT02396511
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Single Patient Treatment Protocol of TRC105 Combined With Standard-dose Bevacizumab for a Single Patient With Metastatic And Refractory Choriocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02396511
First Posted: March 24, 2015
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.
  Purpose
The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of one patient with metastatic and refractory choriocarcinoma.

Condition Intervention Phase
Choriocarcinoma Biological: TRC105 Biological: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Patient Treatment Protocol of TRC105 Combined With Standard-dose Bevacizumab for a Single Patient With Metastatic And Refractory Choriocarcinoma

Resource links provided by NLM:


Further study details as provided by Tracon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: one year ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: one year ]
  • Severity of adverse events (CTCAE) v4 [ Time Frame: one year ]

Enrollment: 1
Study Start Date: January 2015
Estimated Study Completion Date: November 2017
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396511


Locations
United States, Massachusetts
Dana-Farber Cancer Insititue
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
  More Information

Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02396511     History of Changes
Other Study ID Numbers: 105CC201
First Submitted: March 5, 2015
First Posted: March 24, 2015
Last Update Posted: May 17, 2017
Last Verified: January 2016

Additional relevant MeSH terms:
Choriocarcinoma
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Bevacizumab
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors