Breast Cancer Clinical Trial

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

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.

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Full Description

All patients were required to sign a consent form prior to undertaking any study-related procedures. Prospective patients were screened to determine if they qualified for the study within 28 days of enrollment. Patients who qualified received TRC105 i.v. over 1 to 4 hours on Day 1, Day 4, Day 8 and Day 15 of the initial 21-day cycle and Day 1, Day 8 and Day 15 of every subsequent 21-day cycle in combination with 1000 mg/m2 capecitabine BID for 14 days of each 21-day cycle. Those who tolerated TRC105 without any infusion reactions were eligible for reduced infusion durations. After 3 cycles of treatment, patients who demonstrated a response of complete response (CR), partial response (PR) or stable disease (SD) were eligible for additional treatment for up to six months (9 total cycles). Upon discussion with TRACON, patients judged by the Principal Investigator to be benefiting from treatment were able to continue treatment on this protocol beyond six months.

Toxicities were graded according to the NCI CTCAE Version 4.0. Patients who exited the study for reasons other than drug-related toxicity prior to completion of the first 21-day cycle were replaced. Intra-patient dose escalation was not allowed.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

19

Study ID:

NCT01326481

Recruitment Status:

Completed

Sponsor:

Tracon Pharmaceuticals Inc.

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There are 2 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Roswell Park Cancer Institute
Buffalo New York, 14201, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

19

Study ID:

NCT01326481

Recruitment Status:

Completed

Sponsor:


Tracon Pharmaceuticals Inc.

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