Title An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination with Capecitabine for Progressive or Recurrent Metastatic Breast Cancer
Contact ADiRaddo
Principal Investigator Ellis Levine, MD
Study Number 162809
Phase1
Summary
The primary objective 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. The secondary objective of this study is to characterize the pharmacokinetic profile of TRC105 and capecitabine when given in combination as well as to evaluate TRC105 immunogenicity by measuring human antimurine (HAMA) and human antichimeric antibody (HACA) titers.
Eligibility
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)
- Must be at least 18 years old
Exclusion Criteria:
- HER2-positive disease (Part 2 only)
- Prior treatment with more than one systemic, chemotherapy regime for metastatic disease. Prior systemic therapy in the adjuvant setting is not considered a regimen.
- Prior treatment with TRC105
History of hypersensitivity reaction to antimetabolite therapy.