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Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

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ClinicalTrials.gov Identifier: NCT02383927
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kura Oncology, Inc.

Brief Summary:
Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Squamous Head and Neck Cancer HRAS Mutant Tumor Drug: Tipifarnib Phase 2

Detailed Description:

This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations and for whom there is no curative therapy available. Subject with information available on tumor HRAS status previously generated are eligible. All subjects must consent to provide at least 10 tumor slides from a prior diagnostic biopsy for a retrospective testing of RAS gene status at a central facility.

Subjects will be enrolled into two nonrandomized cohorts:

  • Cohort 1: Malignant thyroid tumors with HRAS mutations.
  • Cohort 2: Squamous Head and Neck Cancer with HRAS mutations.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
Thyroid Cancer
Drug: Tipifarnib
FTase inhibitor
Other Name: Zarnestra

Experimental: Cohort 2
Squamous Head and Neck Cancer
Drug: Tipifarnib
FTase inhibitor
Other Name: Zarnestra




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 24 months (approx. 12 months accrual + 12 months follow up) ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 24 months (approx. 12 months accrual + 12 months follow up) ]
  2. Duration of Response (DOR) [ Time Frame: 24 months (approx. 12 months accrual + 12 months follow up) ]
  3. Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Until 30 days after the end of study ]
    Number of patients that experience Adverse Events (AEs). Adverse Events (AEs) and Serious Adverse Events (SAEs) will be graded according to the NCI-CTCAE (Version 4.03).



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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:

  • histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1) or squamous head and neck cancer (cohort 2) for which there is no curative therapy available.
  • tumor that carries a missense HRAS mutation
  • Subject consents to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status
  • Subject has measurable disease according to RECIST v1.1 and has relapsed or is refractory to prior therapy.
  • At least 2 weeks since the last systemic therapy or radiotherapy regimen prior to enrolment
  • ECOG PS 0 or 1
  • Acceptable liver function
  • Acceptable renal function
  • Acceptable hematologic status

Exclusion Criteria:

  • Prior treatment with an FTase inhibitor
  • History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
  • Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Day 1.
  • Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks first dose
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to first dose, without complete recovery.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C

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): NCT02383927


Contacts
Contact: Kamn Lacroix 617-588-3760 medicalaffairs@kuraoncology.com

  Show 25 Study Locations
Sponsors and Collaborators
Kura Oncology, Inc.

Responsible Party: Kura Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02383927     History of Changes
Other Study ID Numbers: KO-TIP-001
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases
Tipifarnib
Antineoplastic Agents