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

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. Identifier: NCT01326481
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : February 7, 2018
Roswell Park Cancer Institute
United States Department of Defense
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: TRC105 Drug: Capecitabine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Primary Completion Date : September 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single
All patients received TRC105 + capecitabine
Drug: TRC105
Drug: Capecitabine

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

Secondary Outcome Measures :
  1. TRC105 pharmacokinetic concentrations [ Time Frame: 1.5 years ]
    Peak and trough concentrations will be evaluated.

  2. Immune response to TRC105 [ Time Frame: 1.5 years ]
    Serial blood samples will be tested for immune response to TRC105.

  3. Objective response according to RECIST 1.1 [ Time Frame: 1.5 years ]
    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

  4. Angiogenic biomarker sample analysis [ Time Frame: 1.5 years ]
    Serial blood samples will be tested for change in angiogenic biomarkers.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01326481

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14201
Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Roswell Park Cancer Institute
United States Department of Defense

Responsible Party: Tracon Pharmaceuticals Inc. Identifier: NCT01326481     History of Changes
Other Study ID Numbers: 105BC102
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: December 2017

Keywords provided by Tracon Pharmaceuticals Inc.:
Breast Cancer
Roswell Park Cancer Institute
Department of Defense

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs