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Trial record 1 of 1 for:    KO-TIP-001
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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 : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Kura Oncology, Inc.

Brief Summary:
Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open

Condition or disease Intervention/treatment Phase
Thyroid Cancer Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) HRAS Mutant Tumor Other Squamous Cell Carcinoma (SCC) With 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. Subjects 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 HRAS gene status at a central facility.

Subjects will be enrolled into three nonrandomized cohorts:

  • Cohort 1: Malignant thyroid tumors with HRAS mutations (cohort is closed).
  • Cohort 2: Squamous Cell Carcinoma Head and Neck Cancer with HRAS mutations.
  • Cohort 3: Squamous Cell Carcinoma (SCC) with HRAS mutations other than HNSCC

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 2020
Estimated Study Completion Date : October 2020

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: Note: Cohort closed to further enrolment) or Squamous Cell Carcinoma head and neck cancer (cohort 2) or Squamous Cell Carcinoma other than HNSCC (cohort 3) for which there is no curative therapy available.
  • tumor that carries a missense HRAS mutation ith a variant allele frequency (VAF) > 20%.
  • 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 • Serum albumin ≥ 3.5 g/dL. Subjects with tumors potentially highly sensitive to tipifarnib (HRAS mutant VAF ≥ 35%) may be enrolled despite a serum albumin < 3.5 g/dL.

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
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Contact: Jeanne Britt 678-777-0686 medicalaffairs@kuraoncology.com

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Sponsors and Collaborators
Kura Oncology, Inc.

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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: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases
Tipifarnib
Antineoplastic Agents