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NCT04865159 · ClinicalTrials.gov registry record · Phase 1
Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies
A Phase 1 study, sponsored by Kura Oncology.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04865159: Clinical Trial Phase 1 study, sponsored by Kura Oncology.
NCT04865159 is a Phase 1 study that was terminated before completion, run by Kura Oncology. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04865159, a Phase 1 study, was terminated before completion, sponsored by Kura Oncology.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
A Phase I, open-label clinical pharmacology study designed to evaluate the effect of tipifarnib on cardiac repolarization (corrected QT interval \[QTc\] duration) following a single dose of 900 mg and after repeated twice daily administration of 600 mg in subjects with advanced solid malignancies. Subjects will receive a 900 mg single dose at cycle 1 day 1 follow by 600 mg twice a day orally with a meal (Days 2-7 and 15-21) in 28-day cycles. Beginning on Day 2 of Cycle 1, subjects will self-administer 600 mg tipifarnib, orally with a meal, bid for 7 days in alternating weeks (Days 2-7 and 15-21) in 28-day cycles. The secondary objectives are to evaluate the safety and PK of tipifarnib. Series of PK will be collected on day -1 of Cycle 1, Cycle 1 day 1 and Cycle 1 day 7.
Primary Outcome
The analysis will be performed using the concentration-QTc modeling approach (Garnett 2018) and the by-time point modeling approach defined in the International Council on Harmonisation (ICH) E14 guidance. The analysis will be performed using triplicate, time-matched ECG measurements of the QTc interval will be taken at baseline, Day 1 (900 mg tipifarnib) and Day 7 (600 mg tipifarnib BID) at predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose (24 hour on day 1 only).
Interventions
- DRUG Tipifarnib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 1 |
Why NCT04865159 stopped before completion
NCT04865159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Tipifarnib is the first listed.
NCT04865159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04865159 about?
NCT04865159 is a clinical study titled "Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies". A Phase I, open-label clinical pharmacology study designed to evaluate the effect of tipifarnib on cardiac repolarization (corrected QT interval \[QTc\] duration) following a single dose of 900 mg and after repeated twice daily administration of 600 mg in subjects with advanced solid malignancies. S...
What is the current status of trial NCT04865159?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-05-06. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT04865159?
The interventions under investigation include: Tipifarnib (DRUG).
Who is sponsoring clinical trial NCT04865159?
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 NCT04865159's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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