CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 296 enrolled
Drug / intervention
Tipifarnib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03719690
NCT03719690Phase 2Completed
CompareCT.gov

A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)

Kura Oncology, Inc.·interventional·Posted Oct 25, 2018·Updated Jun 21, 2024

In Brief

A Phase 2 clinical trial evaluating Tipifarnib and HRAS Detection Assay for HRAS Gene Mutation and HNSCC. Completed, enrolled 296 participants across 102 sites in 16 countries.

Detailed Summary

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHRAS Gene Mutation, HNSCC
CountriesAustralia, Austria, Belgium, Denmark, Germany, Greece, Italy, Malaysia, Netherlands, Norway, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 25, 2018
Enrollment StartMar 15, 2019
Primary CompletionMay 2, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.7 years ago

Interventions

Tipifarnibdrug

Tablet for oral administration

HRAS Detection Assaydevice

In Vitro Assay to detect HRAS mutations