Clinical Phase Ib/II Trial of L-NMMA Plus Docetaxel in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients

Investigator: Polly Niravath, MD

Study Coordinator: Pej Hemati

Status: Enrolling

ClinicalTrials.gov Number: NCT02834403

Phone: 713.441.3926

IRB Number: Pro00011685

Description

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 6 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, and 17.5 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.
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