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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for people with head and neck squamous cell carcinoma.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the recommended dose and regimen and evaluate the safety and tolerability of the combination of tipifarnib and alpelisib
Secondary outcome measures
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 moreTrial 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
2000
Completed Phase 3
~710
Alpelisib
2018
Completed Phase 3
~900
Find a Location
Who is running the clinical trial?
Kura Oncology, Inc.Lead Sponsor
16 Previous Clinical Trials
1,504 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed at least one treatment cycle with specific cancer growth inhibitors.I have a GI condition that could affect how my body absorbs medication.My previous cancer treatment did not work as expected.My cancer originates from the salivary gland, thyroid, or skin.I had major surgery less than 2 weeks ago and haven't fully recovered.My tumor is driven by HRAS or PIK3CA mutations.I am currently on cancer treatment medication.I don't have severe or worsening nerve problems.I am 18 years old or older.I haven't had treatment for heart attack or stroke in the last 6 months.I have been diagnosed with lung inflammation or disease.I have been diagnosed with Type 1 diabetes or my Type 2 diabetes is not well-controlled.My head or neck cancer can't be cured with surgery or radiation.My liver, kidneys, hormone levels, and blood counts are all within normal ranges.I do not have any ongoing serious infections needing treatment.I am fully active or can carry out light work.I can swallow pills or a liquid form of medication without using a feeding tube.
Research Study Groups:
This trial has the following groups:- Group 1: PIK3CA-dependent (Cohort 1)
- Group 2: HRAS-dependent (Cohort 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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