Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy (AIM-HN/SEQ-HN)
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|ClinicalTrials.gov Identifier: NCT03719690|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|HRAS Gene Mutation HNSCC||Drug: Tipifarnib Device: HRAS Detection Assay||Phase 2|
KO-TIP-007 is an international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN) and the impact of HRAS mutations on response to first line systemic therapies for HNSCC (SEQ-HN). KO-TIP-007 has 2 study cohorts. The first study cohort, named AIM-HN, includes HNSCC subjects with HRAS mutations. AIM-HN subjects will receive treatment with tipifarnib and the outcome of this cohort will be evaluated for ORR by an independent review facility.
The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in AIM-HN (HRAS mutant HNSCC) subjects in whom first line outcome data are available and (2) matched control 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.
HNSCC patients in whom HRAS mutations are identified and who meet eligibility criteria will be offered participation in AIM-HN. HNSCC patients in whom HRAS mutations are not identified may participate in SEQ-HN only. These patients will be followed and the comparison of outcomes of HRAS mutant and HRAS wild type HNSCC will address the exploratory objective to determine the effect of HRAS mutation on the ORR of first line systemic therapy in patients with recurrent/metastatic HNSCC. Outcome data from subsequent lines of therapy will be collected.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||November 5, 2018|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
Tablet for oral administration
Device: HRAS Detection Assay
In Vitro Assay to detect HRAS mutations
No Intervention: SEQ-HN
To obtain historical information of first line therapy in subjects enrolled in AIM-HN, in whom first line outcome data are available and (2) matched control 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.
- Objective Response Rate [ Time Frame: 2 years ]complete response and partial response
- Duration of Response [ Time Frame: 2 years ]
- Time to Response [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- One year progression free rate [ Time Frame: 1 year ]
- One year survival [ Time Frame: 1 year ]
- overall survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719690
|Contact: Medical Affairs||617-588-3755||KO-TIPfirstname.lastname@example.org|