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NCT04997902 · ClinicalTrials.gov registry record · Phase 1
Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
A Phase 1 study, sponsored by Kura Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT04997902: Completed Phase 1 study, sponsored by Kura Oncology.
NCT04997902 is a Phase 1 study that has completed, run by Kura Oncology. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04997902, a Phase 1 study, has completed, sponsored by Kura Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.
Primary Outcome
Rate of DLTs evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. A Treatment-Emergent Adverse Event (TEAE) is an AE occurring on or after Cycle 1 Day 1 and within 30 days of the last dose of tipifarnib or alpelisib, whichever is later. Patients with multiple events are counted only once at the highest CTCAE grade.
Interventions
- DRUG Tipifarnib
- DRUG Alpelisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2025-08-29 |
| Phase | Phase 1 |
What the finished NCT04997902 record still lists
NCT04997902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Tipifarnib is the first listed.
NCT04997902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04997902 about?
NCT04997902 is a clinical study titled "Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)". This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.
What is the current status of trial NCT04997902?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-12-07. Estimated completion is 2025-08-29.
What interventions are being tested in trial NCT04997902?
The interventions under investigation include: Tipifarnib (DRUG), Alpelisib (DRUG).
Who is sponsoring clinical trial NCT04997902?
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 NCT04997902's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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