Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
Public ClinicalTrials.gov record NCT03719690. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03719690
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 296 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2019 (Actual)
- Primary completion
- May 2, 2023 (Actual)
- Completion
- May 2, 2023 (Actual)
- Last update posted
- Jun 21, 2024
2019 – 2023
United States locations
- U.S. sites
- 29
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCLA - Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | — |
| UCSF - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| The Oncology Institute of Hope and Innovation - Anaheim | Whittier | California | 90603 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| University of South Florida H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University Of Kansas Medical Center | Westwood | Kansas | 66205 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Marlene and Stewart Greenebaum Cancer Center | Baltimore | Maryland | 21287 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Siteman Cancer Center - Washington University Medical Campus | St Louis | Missouri | 63129 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Texas Health San Antonio - Mays Cancer Center | San Antonio | Texas | 78229 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03719690, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03719690 live on ClinicalTrials.gov.