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History of Changes for Study: NCT02383927
Phase II Study of Tipifarnib in Advanced Cancers With HRAS Mutations
Latest version (submitted May 12, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 3, 2015 None (earliest Version on record)
2 June 4, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 July 10, 2015 Study Status and Contacts/Locations
4 September 17, 2015 Study Status, Contacts/Locations and Study Description
5 October 1, 2015 Study Status and Contacts/Locations
6 August 29, 2016 Study Status
7 September 12, 2016 Study Status, Contacts/Locations, Eligibility, Arms and Interventions, Conditions, Study Description and Study Identification
8 May 14, 2017 Contacts/Locations and Study Status
9 July 15, 2017 Contacts/Locations, Study Status and IPDSharing
10 October 11, 2017 Study Status and Contacts/Locations
11 August 21, 2018 Study Status
12 May 7, 2019 Contacts/Locations, Study Status, Study Description, Eligibility, Study Design and Conditions
13 June 19, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
14 April 26, 2021 Study Status
15 May 12, 2021 Recruitment Status and Study Status
Comparison Format:

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Study NCT02383927
Submitted Date:  March 3, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: KO-TIP-001
Brief Title: Phase II Study of Tipifarnib in Advanced Cancers With HRAS Mutations
Official Title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2015
Overall Status: Not yet recruiting
Study Start: March 2015
Primary Completion: March 2017 [Anticipated]
Study Completion: December 2017 [Anticipated]
First Submitted: February 20, 2015
First Submitted that
Met QC Criteria:
March 3, 2015
First Posted: March 10, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 3, 2015
Last Update Posted: March 10, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Kura Oncology, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available.
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: Non-hematological malignancies with HRAS mutations.
Open or close this module Conditions
Conditions: Thyroid Cancer
Advanced Non-hematological Malignancies
HRAS Mutant Tumor
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cohort 1
Thyroid Cancer
Drug: Tipifarnib
FTase inhibitor
Other Names:
  • Zarnestra
Experimental: Cohort 2
Non-hematological malignancies
Drug: Tipifarnib
FTase inhibitor
Other Names:
  • Zarnestra
Open or close this module Outcome Measures
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).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • histologically or cytologically confirmed diagnosis of non-hematological malignancy 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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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