This trial is active, not recruiting.

Condition metastatic breast cancer
Treatment trc105
Phase phase 1/phase 2
Target CD105
Sponsor Tracon Pharmaceuticals Inc.
Collaborator Roswell Park Cancer Institute
Start date June 2011
End date September 2014
Trial size 30 participants
Trial identifier NCT01326481, 105BC102


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Determine Maximum Tolerated Dose of TRC105 in Combination with Capecitabine
time frame: 1.5 years

Secondary Outcomes

TRC105 pharmacokinetic concentrations
time frame: 1.5 years
Immune response to TRC105
time frame: 1.5 years
Objective response according to RECIST 1.1
time frame: 1.5 years
Angiogenic biomarker sample analysis
time frame: 1.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Tracon Pharmaceuticals Inc..