advanced cancer cancer with a specific genetic mutation
Conditions
Interventions
Tipifarnib will be administered at a dose of 600 mg, orally, twice daily, on
days 1-7 and 15-21 of 28 day treatment cycles. If no unmanageable toxicities
occur, subjects may continue to receive the
Sponsors
Kura Oncology, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject is at least 18 years of age. - Subject has a histologically or cytologically confirmed diagnosis of non-hematological malignancy for which there is no curative therapy available - Subject has a tumor that carries a missense HRAS mutation according to a methodology approved by the Sponsor. - Subject has measurable disease according to RECIST v1.1 and has relapsed (progressive disease) or is refractory to prior therapy
Exclusion criteria
Exclusion criteria: - Ongoing treatment with an anticancer agent not contemplated in this protocol. - Prior treatment (at least 1 full treatment cycle) with an FTase inhibitor. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response assessments according to RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events (TEAE) and SAEs evaluated according to NCI CTCAE v.4.03 | — |
Countries
Netherlands
Outcome results
None listed