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Trial record 1 of 1 for:    NCT03719690
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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 : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Kura Oncology, Inc.

Brief 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 and includes 2 types of patients: (1) the historical record of first line therapy in subjects with HRAS mutant HNSCC participating in Cohort 1 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.

Condition or disease Intervention/treatment Phase
HRAS Gene Mutation HNSCC Drug: Tipifarnib Device: HRAS Detection Assay Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AIM-HN
Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
Drug: Tipifarnib
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.



Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 years ]
    complete response and partial response


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 2 years ]
  2. Time to Response [ Time Frame: 2 years ]
  3. Progression Free Survival [ Time Frame: 2 years ]
  4. One year progression free rate [ Time Frame: 1 year ]
  5. One year survival [ Time Frame: 1 year ]
  6. overall survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

AIM-HN

  1. At least 18 years of age.
  2. Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
  3. Documented tumor progression or recurrence from at least one prior platinum-containing regimen in the primary, neoadjuvant, adjuvant, advanced, recurrent or metastatic setting.
  4. Known tumor missense HRAS mutation.
  5. Measurable disease by RECIST v1.1.
  6. ECOG performance status of 0-2.
  7. Acceptable liver, renal and hematological function

Exclusion Criteria:

  1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
  2. Received treatment for unstable angina within prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
  3. Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
  4. Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy. Known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C.
  5. Received treatment for non-cancer related liver disease within prior year.

Inclusion Criteria: SEQ-HN

  1. At least 18 years of age.
  2. Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
  3. Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.

Exclusion Criteria: SEQ-HN

1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).


Information from the National Library of Medicine

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


Contacts
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Contact: Karen Bracken 704-707-5345 karen@kuraoncology.com
Contact: Jeanne Britt 678-777-0686 jeanne@kuraoncology.com

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Tennessee
Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Kura Oncology, Inc.

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Responsible Party: Kura Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03719690     History of Changes
Other Study ID Numbers: KO-TIP-007
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Kura Oncology, Inc.:
TIPIFARNIB
HEAD AND NECK CANCER
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Tipifarnib
Antineoplastic Agents