Status:
TERMINATED
Cardiovascular Safety Study of Tipifarnib in Patients With Advanced Solid Malignancies
Lead Sponsor:
Kura Oncology, Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- At least 18 years of age.
- Advanced solid tumor malignancies for whom no other therapy or intervention is available
- Confirmation of measurable disease by RECIST v1.1
- No uncontrolled hypertension, defined as \>140/90 mm Hg
- A normal 12-lead ECG
- At least two weeks since the last systemic anticancer therapy regimen prior to Cycle 1 Day 1; this includes radiation therapy.
- ECOG performance status of 0-2.
- Acceptable liver, renal and hematological function
- Other protocol defined inclusion criteria may apply.
- Exclusion Criteria
- Has disease that is suitable for therapy administered with curative intent.
- Ongoing treatment with another anticancer agent indicated for the malignancy for which the subject is enrolling into the study (excluding adjuvant hormonal therapy for breast cancer and hormonal treatment for castration sensitive prostate cancer).
- History of cardiomyopathy, unstable angina within prior 6 months, myocardial infarction within prior 6 months, cerebrovascular attack within prior 6 months, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication.
- Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
- Major surgery, other than diagnostic surgery, within 14 days prior to Cycle 1 Day 1, without complete recovery.
- Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy.
- Other protocol defined exclusion may apply
Exclusion
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04865159
Start Date
May 6 2021
End Date
May 2 2023
Last Update
September 21 2023
Active Locations (3)
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1
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
2
NEXT Oncology
Austin, Texas, United States, 78758
3
NEXT Oncology
San Antonio, Texas, United States, 78229