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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: Completed Phase 1 study, sponsored by The Methodist Hospital Research Institute.
NCT02834403 is a Phase 1 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2. As patients are accrued, a standard Bayesian model averaging continual reassessment method (CRM) approach will be used to determine the appropriate dosage. For a dose level to be chosen as the MTD, at least 4 patients must have
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 |
What the finished NCT02834403 record still lists
NCT02834403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT02834403 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02834403's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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