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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT01326481

Run by

Tracon Pharmaceuticals Inc.

People needed

19

Starts

2011-06-01

Expected to finish

2014-12-01

Last updated by the study team

2019-03-18

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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