A research study to find out whether tipifarnib is safe and effective for the treatment of a type of cancer that has a specific genetic mutation and for which there is no curative therapy available.

Phase 1

• Conditions: Advanced non-haematological malignancies with HRAS.; MedDRA version: 20.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10071971Term: H-ras gene mutationSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 20.0Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004535-12-GB
• Lead Sponsor: Kura Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-08
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

**Over 18 yrs
**Histologically or cytologically confirmed diagnosis of non-hematological malignancy for which there is no curative therapy available.
**Tumour that carries a missense HRAS mutation
**Subject consents to provide at least 10 unstained tumour slides (or equivalent tumour tissue blocks) for retrospective testing of HRAS gene tumour 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 heamatologic status
** Female subjects must be either:
a. Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal);
or
b. Of childbearing potential,must use a highly effective method of contraception, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence. Both females and male subjects with female partners of child-bearing potential must agree to use a highly effective method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

**Ongoing treatment with an anticancer agent
**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
** Subjects who have exhibited allergic reactions to tipifarnib or structural compounds similar to tipifarnib or to the drug product excipients.
** Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified