drugset
drugset / Trial / NCT02834403

L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients

NCT02834403 ↗

Phase 1/2 Completed 37 enrolled The Methodist Hospital Research Institute
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2016-11
Primary completion
2021-01
Completion
2021-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 100 mg/m2 Intravenous
Subject L-NMMA Unknown 5 mg/kg Intravenous
Subject L-NMMA Unknown 7.5 mg/kg Intravenous
Subject L-NMMA Unknown 10 mg/kg Intravenous
Subject L-NMMA Unknown 12.5 mg/kg Intravenous
Subject L-NMMA Unknown 15 mg/kg Intravenous
Subject L-NMMA Unknown 17.5 mg/kg Intravenous
Subject L-NMMA Unknown 20 mg/kg Intravenous
Background Amlodipine Other / unclassified 10 mg Oral
Background Aspirin Small molecule 81 mg Oral
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

triple-negative breast carcinoma