Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Kura Oncology.
NCT03719690 is a Phase 2 study that has completed, run by Kura Oncology. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRF. 95% confidence interval (CI) was calculated by the exact binomial (Clopper-Pearson) method.
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 |
What the finished NCT03719690 record still lists
NCT03719690 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 2 interventions - of which Tipifarnib is the first listed.
NCT03719690 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03719690's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05563792 · 296 participants · NA
Options for Pain Management Using Nonpharmacological Strategies
- NCT06828445 · 296 participants · Phase 1
Increasing Affordable Fruits and Vegetables for Families With Food Insecurity
- NCT06920563 · 296 participants · NA
Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education
- NCT06309160 · 297 participants · NA
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI