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NCT02834403 · ClinicalTrials.gov registry record · Phase 1
L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
A Phase 1 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT02834403 is a Phase 1 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 37 participants.
The verdict
NCT02834403, a Phase 1 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study 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.
Interventions
- DRUG Docetaxel
- DRUG Amlodipine
- DRUG L-NMMA
- DRUG Pegfilgrastim
- DRUG Enteric-coated aspirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-11 |
| Est. Completion | 2021-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02834403
The ClinicalTrials.gov registry entry for NCT02834403 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT02834403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02834403 about?
NCT02834403 is a clinical study titled "L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients". 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 t...
What is the current status of trial NCT02834403?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2016-11. Estimated completion is 2021-01.
What interventions are being tested in trial NCT02834403?
The interventions under investigation include: Docetaxel (DRUG), Amlodipine (DRUG), L-NMMA (DRUG), Pegfilgrastim (DRUG), Enteric-coated aspirin (DRUG).
Who is sponsoring clinical trial NCT02834403?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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