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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 is a Phase 1 study that was terminated before completion, run by Kura Oncology. The registered enrollment target is 6 participants.
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.
Interventions
- DRUG Tipifarnib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04865159
The ClinicalTrials.gov registry entry for NCT04865159 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 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 1 intervention - of which Tipifarnib is the first listed.
NCT04865159 reports 0 study locations.
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.
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