At a glance
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Clinical Phase Ib/II Trial of L-NMMA Plus Taxane Chemotherapy in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating L-NMMA, Docetaxel, and 3 other interventions for Metastatic Triple Negative Breast Cancer. Completed, enrolled 37 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Nitric oxide synthase inhibitor
Mitotic inhibitor, cytotoxic
Long-acting calcium channel blocker
Colony-stimulating factor
non-steroidal anti-inflammatory drug