L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
Status:
Completed
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase Ib/II study assessing the maximum tolerated dose (MTD), dose-limiting
toxicities (DLTs), recommended Phase 2 dose (RP2D), and efficacy of L-NMMA when combined with
docetaxel in refractory locally advanced or metastatic triple negative breast cancer
patients. The Phase Ib portion of the study is designed to investigate the combination at two
dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5,
15, 17.5, and 20 mg/kg). The starting dose of L-NMMA will be 7.5 mg/kg. In the Phase II
portion of the study, the starting dose will be the RP2D determined in the Phase Ib portion
of the study.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Angel Augusto Rodriguez, MD The Methodist Hospital Research Institute