NCT03719690Phase 2Completed

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

Study sponsor: Kura Oncology, Inc. · KURA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-05-02Actual

Enrollment · participants296Actual

Source updated2024-06-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

HRAS Gene Mutation; HNSCC

Treatments or interventions studied

TipifarnibDrug

Primary outcomes · main study measures

Read the study measures

measure: Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF); description: ORR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRF. 95% confidence interval (CI) was calculated by the exact binomial (Clopper-Pearson) method.; timeFrame: Up to approximately 28 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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