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

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ClinicalTrials.gov Identifier: NCT02396511
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Choriocarcinoma Biological: TRC105 Biological: Bevacizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Treatment Protocol of TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma
Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma [ Time Frame: Assessed every 8 weeks for up to 35 Months ]
    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.

  2. Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG [ Time Frame: Assessed every 8 weeks for up to 35 Months ]

    To determine the Objective Response Rate of two patients with metastatic and refractory choriocarcinoma by RECIST 1.1 including measurement of serum β- hCG. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) categorizes response as:

    Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR



Secondary Outcome Measures :
  1. Frequency and Severity of Adverse Events [ Time Frame: Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months. ]
    Adverse event frequency and severity according to CTCAE version 4.0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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United States, Massachusetts
Dana-Farber Cancer Insititue
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Investigators
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Study Director: Charles Theuer, MD Medical Monitor
  Study Documents (Full-Text)

Documents provided by Tracon Pharmaceuticals Inc.:

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Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02396511     History of Changes
Other Study ID Numbers: 105CC201 & 105CC201B
First Posted: March 24, 2015    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors