A Phase I, Single Center, Open-label Clinical Pharmacology Study to Evaluate the Effect of Tipifarnib on Cardiac Safety in Subjects With Advanced Solid Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Tipifarnib will be administered with a meal at a starting single dose of 900 mg, orally, once on Day 1, Cycle 1 followed by 600 mg, orally bid on Cycle 1 Days 2-7 and Days 15-21 for a 28-day treatment cycle.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Phase I study will 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. The study will enroll approximately 20 subject...
Phase I study will 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. The study will enroll approximately 20 subjects with advanced solid malignancies (at least 8, but no more than 12, male subjects). Subjects must have no approved/appropriate therapeutic options available. Subject will undergo series of ECG at Cycle 1 day -1 follow by study drug dosing, series of Pharmacokinetic and ECG at Cycle 1 day 1 and Cycle 1 day 7. 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. For Cycle 2 and beyond, subjects will self-administer 600 mg bid on Days 1-7 and Days 15-21 in 28-day cycles.
Tracking Information
- NCT #
- NCT04865159
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Sommerhalder, MD NEXT Oncology
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