Trial record 1 of 1 for:    TRC105 Progressive or Recurrent Metastatic Breast Cancer
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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

March 25, 2011
May 5, 2014
June 2011
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01326481 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: TRC105
IV
Single
Intervention: Drug: TRC105
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bonne Adams, MBA 8585500780 ext 228 badams@traconpharma.com
United States
 
NCT01326481
105BC102
Yes
Tracon Pharmaceuticals Inc.
Tracon Pharmaceuticals Inc.
  • Roswell Park Cancer Institute
  • Department of Defense
Not Provided
Tracon Pharmaceuticals Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP