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PI3K Inhibitor

Tipifarnib + Alpelisib for Head and Neck Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Kura Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a tumor that is dependent upon HRAS and/or PIK3CA
At least 18 years of age
Must not have
Prior treatment (at least 1 full treatment cycle) with an FTI or PI3K, mTOR, or AKT inhibitor
Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (eg, mucosal melanoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of two drugs, tipifarnib and alpelisib, in patients with advanced head and neck cancer that have specific genetic changes. The drugs aim to stop cancer growth by blocking essential enzymes. Tipifarnib is a farnesyl transferase inhibitor that has shown clinical activity in head and neck squamous cell carcinoma, particularly in tumors with HRAS mutations.

Who is the study for?
Adults over 18 with recurrent/metastatic head and neck squamous cell carcinoma not suitable for curative surgery or radiation. Must have failed at least one systemic therapy, have an ECOG performance status of 0-1, measurable disease by RECIST v1.1, HRAS-dependent and/or PIK3CA-mutated/amplified tumors, good organ function, and be able to swallow medication.
What is being tested?
The trial is testing a combination of two drugs: Tipifarnib (a farnesyltransferase inhibitor) and Alpelisib (a PI3K inhibitor), in patients whose tumors overexpress the HRAS protein or are PIK3CA-mutated/amplified. It's a phase 1/2 study which means it's looking at safety as well as efficacy.
What are the potential side effects?
Potential side effects may include skin reactions, increased risk of infections due to immune system suppression, liver problems, kidney issues, blood sugar changes (especially important for diabetics), gastrointestinal disturbances that could affect drug absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is driven by HRAS or PIK3CA mutations.
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I am 18 years old or older.
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My head or neck cancer can't be cured with surgery or radiation.
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I am fully active or can carry out light work.
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I can swallow pills or a liquid form of medication without using a feeding tube.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have completed at least one treatment cycle with specific cancer growth inhibitors.
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My cancer originates from the salivary gland, thyroid, or skin.
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I had major surgery less than 2 weeks ago and haven't fully recovered.
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I am currently on cancer treatment medication.
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I don't have severe or worsening nerve problems.
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I haven't had treatment for heart attack or stroke in the last 6 months.
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I have been diagnosed with lung inflammation or disease.
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I have been diagnosed with Type 1 diabetes or my Type 2 diabetes is not well-controlled.
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I do not have any ongoing serious infections needing treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the recommended dose and regimen and evaluate the safety and tolerability of the combination of tipifarnib and alpelisib
Secondary study objectives
AUC(0-infinity) of tipifarnib and alpelisib when administered in combination
AUC(0-last) of tipifarnib and alpelisib when administered in combination
AUC(tau) of tipifarnib and alpelisib when administered in combination
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PIK3CA-dependent (Cohort 1)Experimental Treatment2 Interventions
Adult participants with R/M HNSCC whose tumors harbor PI3KCA (activating) mutations and/or amplifications
Group II: HRAS-dependent (Cohort 2)Experimental Treatment2 Interventions
Adult participants with R/M HNSCC whose tumors have increased HRAS dependency, defined as HRAS overexpression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tipifarnib
2019
Completed Phase 3
~1000
Alpelisib
2018
Completed Phase 3
~960

Find a Location

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor
18 Previous Clinical Trials
1,694 Total Patients Enrolled

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04997902 — Phase 1 & 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: PIK3CA-dependent (Cohort 1), HRAS-dependent (Cohort 2)
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT04997902 — Phase 1 & 2
Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997902 — Phase 1 & 2
~10 spots leftby Nov 2025
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