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Farnesyltransferase Inhibitor

Tipifarnib for Gene Mutation (AIM-HN/SEQ-HN Trial)

Phase 2

Waitlist Available

Research Sponsored by Kura Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

AIM-HN/SEQ-HN Trial Summary

This trialstudies an experimental drug for people with head and neck cancer who have a certain gene change. It will look at the response rate and outcomes for those with and without the gene change.

Eligible Conditions

Gene Mutation
Head and Neck Squamous Cell Carcinoma

AIM-HN/SEQ-HN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate in High Variable Allele Frequency (VAF) population

Secondary outcome measures

Duration of Response in High VAF population

Duration of Response in any VAF population

Evaluate the concentration of tipifarnib [pharmacokinetics (PK)] in blood samples over time

+8 more

Side effects data

From undefined Phase 3 trial • 144 Patients • NCT00093470

58%

White blood cell decreased

56%

Anemia

54%

Platelet count decreased

35%

Neutrophil count decreased

Fatigue

Rash maculo-papular

Myalgia

Febrile neutropenia

Confusion

Infections and infestations - Other, specify

Catheter related infection

Hypokalemia

Peripheral sensory neuropathy

Eye disorders - Other, specify

Back pain

Treatment related secondary malignancy

Psychosis

Agitation

Acute coronary syndrome

Diarrhea

Nausea

Lung infection

Peripheral nerve infection

Sinusitis

Alanine aminotransferase increased

Aspartate aminotransferase increased

GGT increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm A (Tipifarnib)

Arm B (Clinical Observation)

AIM-HN/SEQ-HN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AIM-HNExperimental Treatment2 Interventions

Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles

Group II: SEQ-HNActive Control1 Intervention

HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tipifarnib

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor

15 Previous Clinical Trials

1,238 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for participants in this clinical trial?

"Currently, this particular clinical trial is not recruiting patients. Although, it was first posted on 11/5/2018 and last edited on 11/6/2022. If you are interested in other studies, there are presently 505 trials actively looking for participants with oral squamous cell carcinoma and 6 trials for Tipifarnib actively admitting patients."

Answered by AI

Has Tipifarnib been studied before in other medical trials?

"The first study involving tipifarnib was completed in 2017 at the Riley Hospital for Children. Since then, there have been a total of 48 studies (6 of which are ongoing). There is a significant presence of research being done on tipifarnib out of Baltimore, Maryland."

Answered by AI

Does Tipifarnib have a large margin of safety?

"While there is some evidence pointing to the Tipifarnib's safety, as this is only a Phase 2 trial, it cannot yet be said to be effective. Consequently, it received a score of 2."

Answered by AI

How many people can potentially enroll in this experiment?

"As of right now, this study is no longer looking for participants. It was originally posted on November 5th, 2018 but the most recent edit occurred on November 6th, 2020. There are currently 505 studies actively recruiting patients with oral squamous cell carcinoma and 6 studies involving Tipifarnib that are still enrolling patients."

Answered by AI

Are there hospitals in North America that are testing this medication?

"Presently, this clinical study is enrolling patients at 29 cancer research centres across America. A few locations include Marlene and Stewart Greenebaum Cancer Center in Baltimore, Dana Farber Cancer Institute in Boston, and Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center in Nashville, Tennessee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

2018. "Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03719690.