Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer (TRC105)
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ClinicalTrials.gov Identifier: NCT01326481
Verified May 2014 by Tracon Pharmaceuticals Inc.. Recruitment status was: Active, not recruiting
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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