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An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer

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Trial Information

An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine Maximum Tolerated Dose of TRC105 in Combination with Capecitabine

Outcome Description:

Assess safety and dose limiting toxicity by dose cohort.

Outcome Time Frame:

1.5 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

105BC102

NCT ID:

NCT01326481

Start Date:

June 2011

Completion Date:

December 2013

Related Keywords:

  • Metastatic Breast Cancer
  • TRC105
  • Breast Cancer
  • CD105
  • Endoglin
  • TRACON Pharma
  • Roswell Park Cancer Institute
  • Department of Defense
  • Breast Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Alabama at BirminghamBirmingham, Alabama  35294-3300