Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
NCT ID: NCT04997902
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2021-12-07
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PIK3CA-dependent (Cohort 1)
Adult participants with R/M HNSCC whose tumors harbor PI3KCA (activating) mutations and/or amplifications
Tipifarnib
Oral administration
Alpelisib
Oral administration
HRAS-dependent (Cohort 2)
Adult participants with R/M HNSCC whose tumors have increased HRAS dependency, defined as HRAS overexpression
Tipifarnib
Oral administration
Alpelisib
Oral administration
Interventions
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Tipifarnib
Oral administration
Alpelisib
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed head and neck cancer of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
3. Documented treatment failure from at least 1 prior systemic therapy in the R/M setting, unless determined not appropriate.
4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Has a tumor that is dependent upon HRAS and/or PIK3CA.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Acceptable liver, renal, endocrine, and hematologic function.
8. Must be able to swallow alpelisib whole tablet or oral suspension containing crushed tablets. Feeding tube may not be used for alpelisib administration.
Exclusion Criteria
2. Ongoing treatment with certain anticancer agents.
3. Prior treatment (at least 1 full treatment cycle) with an FTI or PI3K, mTOR, or AKT inhibitor.
4. Received treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months.
5. Non-tolerable Grade 2, or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
6. Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
7. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
8. Participant with an established diagnosis of diabetes mellitus Type 1 or not controlled Type 2.
9. Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs based on Investigator discretion.
10. Participant has currently documented pneumonitis/interstitial lung disease.
11. Participant has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
18 Years
ALL
No
Sponsors
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Kura Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Lake Nona DDU (Florida Cancer Specialists)
Orlando, Florida, United States
University of Maryland School of Medicine (Marlene and Stewart Greenebaum Comprehensive Cancer Center)
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine (Sidney Kimmel Comprehensive Cancer Center)
Baltimore, Maryland, United States
Dana-Farber Cancer Institute (Head and Neck Cancer Treatment Center)
Boston, Massachusetts, United States
Washington University, School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center (Harold C. Simmons Comprehensive Cancer Center)
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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KO-TIP-013
Identifier Type: -
Identifier Source: org_study_id