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NCT03719690 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
A Phase 2 study, sponsored by Kura Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
NCT03719690 is a Phase 2 study that has completed, run by Kura Oncology. The registered enrollment target is 296 participants.
The verdict
NCT03719690, a Phase 2 study, has completed, sponsored by Kura Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
Study Summary
An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Interventions
- DRUG Tipifarnib
- DEVICE HRAS Detection Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03719690
The ClinicalTrials.gov registry entry for NCT03719690 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kura Oncology, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tipifarnib is the first listed.
NCT03719690 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03719690 about?
NCT03719690 is a clinical study titled "Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy". An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, S...
What is the current status of trial NCT03719690?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2019-03-15. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT03719690?
The interventions under investigation include: Tipifarnib (DRUG), HRAS Detection Assay (DEVICE).
Who is sponsoring clinical trial NCT03719690?
This trial is sponsored by Kura Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
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