Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Tracon Pharmaceuticals Inc.
Sponsor:
Collaborators:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01326481
First received: March 25, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: TRC105
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Tracon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Determine Maximum Tolerated Dose of TRC105 in Combination with Capecitabine [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    Assess safety and dose limiting toxicity by dose cohort.


Secondary Outcome Measures:
  • TRC105 pharmacokinetic concentrations [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    Peak and trough concentrations will be evaluated.

  • Immune response to TRC105 [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    Serial blood samples will be tested for immune response to TRC105.

  • Objective response according to RECIST 1.1 [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    The best response according to RECIST 1.1 for each patient with measurable disease who received at least one dose of study drug will be listed by cohort and tumor type

  • Angiogenic biomarker sample analysis [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    Serial blood samples will be tested for change in angiogenic biomarkers.


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Drug: TRC105
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only)
  • Histologically proven metastatic Her-2-negative breast cancer (Part 2 only)
  • Measurable disease by RECIST 1.1 criteria (Part 2 only)
  • Willing and able to consent for self to participate in study
  • Progressive or recurrent disease after prior systemic chemotherapy regimen
  • Age ≥ 18 years
  • ECOG performance status of 0 or 1
  • Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)
  • Adequate organ function

Exclusion Criteria:

  • Prior treatment with more than one systemic chemotherapy regimen for metastatic disease.
  • Prior treatment with TRC105
  • History of hypersensitivity reaction to antimetabolite therapy
  • Receipt of an investigational agent within 28 days of starting study treatment
  • Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment
  • Minor surgical procedures within 14 days prior to first dose of TRC105
  • History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
  • Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months
  • Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy
  • Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia
  • Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105
  • Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last month
  • Hemorrhage within 28 days of starting study treatment
  • Unhealed wounds within 28 days of starting study treatment
  • History of peptic ulcer disease or 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
  • Known active viral or nonviral hepatitis
  • History of hypersensitivity reaction to human or mouse antibody products
  • Lung cancer with central chest lesions
  • Pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326481

Contacts
Contact: Bonne Adams, MBA 8585500780 ext 228 badams@traconpharma.com

Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294-3300
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14201
Contact: Amy Whitworth, RN       amy.whitworth@roswellpark.org   
Principal Investigator: Ellis Levine, MD         
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01326481     History of Changes
Other Study ID Numbers: 105BC102
Study First Received: March 25, 2011
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tracon Pharmaceuticals Inc.:
TRC105
Breast Cancer
CD105
Endoglin
TRACON Pharma
Roswell Park Cancer Institute
Department of Defense

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014