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Trial record 1 of 1 for:    NCT02664961
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Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

This study is currently recruiting participants.
Verified November 2016 by Tracon Pharmaceuticals Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02664961
First Posted: January 27, 2016
Last Update Posted: November 2, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.
  Purpose
The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT)). Up to 30 patients will be treated.

Condition Intervention Phase
Gestational Trophoblastic Neoplasia Choriocarcinoma Placental Site Trophoblastic Tumor Epithelioid Trophoblastic Tumor Drug: TRC105 Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A Study of TRC105 (With Option to Add Bevacizumab) in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

Resource links provided by NLM:


Further study details as provided by Tracon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Preliminary Evidence of Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed by Overall Response Rate (ORR). [ Time Frame: 20 months ]

Secondary Outcome Measures:
  • Preliminary evidence of antitumor activity of TRC105 will be assessed by Progression-Free Survival (PFS). [ Time Frame: 20 months ]
  • Preliminary evidence of antitumor activity of single agent bevacizumab will be assessed by Overall Response Rate (ORR). [ Time Frame: 20 months ]
  • Changes in circulating angiogenic biomarkers following treatment with TRC105 and bevacizumab. [ Time Frame: 20 months ]
  • Maximum plasma concentration (Cmax) of TRC105. [ Time Frame: 20 months ]
  • TRC105 immunogenicity as assessed by Anti-Product Antibody (APA). [ Time Frame: 20 months ]
  • Frequency and severity of adverse events as assessed by NCI CTCAE (Version 4.03). [ Time Frame: 20 months ]
  • Maximum plasma concentration (Cmax) of bevacizumab. [ Time Frame: 20 months ]

Estimated Enrollment: 30
Study Start Date: March 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRC105 and/or bevacizumab
All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.
Drug: TRC105
Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.
Other Name: Chimeric Antibody (TRC105) to CD105
Drug: Bevacizumab
Bevacizumab will be dosed every two weeks.
Other Name: Avastin

Detailed Description:
TRC105 is a monoclonal antibody that binds to endoglin, an angiogenic target highly expressed on the tumor vessels and tumor cells in gestational trophoblastic neoplasia (GTN). 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 has been well tolerated as a single agent and when combined with bevacizumab. These antibodies may be efficacious in refractory GTN, a tumor type that is highly vascular and has been shown to densely express endoglin.
  Eligibility

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Ages Eligible for Study:   16 Years to 99 Years   (Child, 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 study procedures
  3. Elevated serum hCG (in cases of choriocarcinoma); elevated hCG or measurable disease (in cases of PSTT or ETT)
  4. Histologically proven trophoblastic neoplasia, or clinically demonstrated trophoblastic neoplasia that has progressed following treatment with at least one chemotherapy regimen that included 2 or more chemotherapy agents.
  5. Age of 16 years or older
  6. ECOG performance status ≤ 1
  7. Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline
  8. Adequate organ function

Exclusion Criteria:

  1. Prior treatment with TRC105
  2. Current treatment on another therapeutic clinical trial
  3. Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy
  4. Significant pericardial effusion, pleural effusion, or ascites
  5. Active bleeding or pathologic condition that carries a high risk of bleeding
  6. Tumors located in the central chest or other location where bleeding is associated with high morbidity
  7. Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
  8. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the past 6 months. Deep venous thrombosis within 6 months, unless the patient is therapeutically anti-coagulated for at least 2 weeks. In this situation, low molecular weight heparin is preferred
  9. Known active viral or nonviral hepatitis
  10. Pregnant or actively breastfeeding without intention to discontinue prior to initiation of study
  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. History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved
  14. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
  15. 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
  16. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for brain edema for at least 28 days
  17. Receipt of systemic anticancer therapy, including investigational agents, within 28 days of starting study treatment. If anticancer therapy was given within 28 days of starting study treatment, patients may be included if 5 times the elimination half-life of the drug has passed
  18. Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation < 14 days prior to starting study treatment or those patients who have not recovered adequately from side effects of such therapy
  19. Major surgical procedure or significant traumatic injury within 6 weeks prior to study registration or not fully recovered from any such procedure
  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): NCT02664961


Contacts
Contact: Clinical Trials Information Clinicaltrials@traconpharma.com

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Colleen Pineda, CCRC    614-366-9078    Colleen.Pineda@osumc.edu   
Principal Investigator: David M O'Malley, MD         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Tiffany Thomas, BSN, RN    214-648-7094    tiffany.thomas@utsouthwestern.edu   
Principal Investigator: David Miller, MD         
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Investigators
Study Director: Charles Theuer, MD, PhD Tracon Pharmaceuticals Inc.
  More Information

Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02664961     History of Changes
Other Study ID Numbers: 105GTN201
First Submitted: January 20, 2016
First Posted: January 27, 2016
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tracon Pharmaceuticals Inc.:
TRC105
CD105
Endoglin
Angiogenesis inhibitor
GTN
Bevacizumab
Avastin

Additional relevant MeSH terms:
Neoplasms
Choriocarcinoma
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Trophoblastic Tumor, Placental Site
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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