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NCT02097225 · ClinicalTrials.gov registry record · Phase 1
Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02097225: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02097225 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02097225, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of onalespib when given together with dabrafenib and trametinib in treating patients with BRAF-mutant melanoma or solid tumors that have spread to another place in the body (metastatic) or cannot be removed by surgery. Onalespib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Maximum tolerated dose is defined as the highest dose level at which 0 or 1 of six patients has experienced a dose limiting toxicity (DLT) within 28 days after start of treatment. Toxicities will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. Participant enrollment occurred from July 2015 to June 2018, spanning Dose Levels 1-4. * Dose Level 1 (starting dose): * Dabrafenib = 150 mg * Trametinib = 1 mg * Onalespib = 180 mg/m2 * Dose Level 2:
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Trametinib
- DRUG Dabrafenib
- OTHER Pharmacological Study
- DRUG Onalespib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-05-29 |
| Est. Completion | 2022-10-26 |
| Phase | Phase 1 |
Why NCT02097225 stopped before completion
NCT02097225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02097225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02097225 about?
NCT02097225 is a clinical study titled "Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of onalespib when given together with dabrafenib and trametinib in treating patients with BRAF-mutant melanoma or solid tumors that have spread to another place in the body (metastatic) or cannot be removed by surgery. Onalespib, dabrafenib, ...
What is the current status of trial NCT02097225?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2014-05-29. Estimated completion is 2022-10-26.
What interventions are being tested in trial NCT02097225?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Trametinib (DRUG), Dabrafenib (DRUG), Pharmacological Study (OTHER), Onalespib (DRUG).
Who is sponsoring clinical trial NCT02097225?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02097225's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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