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NCT03719690 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Kura Oncology.

Completed
Registry status
Phase 2
Development phase
296
Enrollment target

NCT03719690 is a Phase 2 study that has completed, run by Kura Oncology. The registered enrollment target is 296 participants.

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The verdict

NCT03719690, a Phase 2 study, has completed, sponsored by Kura Oncology.

COMPLETED
Registry status
Phase 2
Development phase
296 participants
Enrollment target

Study 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.

Interventions

  • DRUG Tipifarnib
  • DEVICE HRAS Detection Assay

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2019-03-15
Est. Completion 2023-05-02
Phase Phase 2

Sponsor

Kura Oncology

14 total trials

What the Registry Record Tells You About NCT03719690

The ClinicalTrials.gov registry entry for NCT03719690 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kura Oncology, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Tipifarnib is the first listed.

NCT03719690 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03719690 about?

NCT03719690 is a clinical study titled "Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy". 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, S...

What is the current status of trial NCT03719690?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2019-03-15. Estimated completion is 2023-05-02.

What interventions are being tested in trial NCT03719690?

The interventions under investigation include: Tipifarnib (DRUG), HRAS Detection Assay (DEVICE).

Who is sponsoring clinical trial NCT03719690?

This trial is sponsored by Kura Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.