Primary objective: To determine the antitumor activity regarding objective response rate (ORR) of tipifarnib in subjects with locally advanced non-resectable or metastatic, relapsed and/or refractory, non-haematological malignancies with HRAS…
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Response assessments according to RECIST 1.1
Secondary outcome
Treatment-emergent adverse events (TEAE) and SAEs evaluated according to NCI
CTCAE v.4.03
Background summary
This phase II study will investigate the antitumor activity regarding the ORR
of tipifarnib in subjects with locally advanced tumors who are carriers of HRAS
mutations and for whom no curative treatment is available. Enrolling subjects
may continue based on prior obtained information in the clinical study sites on
the HRAS status of the tumor. However, all subjects, except those with
anaplastic thyroid gland tumors, must consent to give at least 10 tumor slides
(or equivalent tumor tissue block) of a prior diagnostic biopsy for a
retrospective test of the RAS gene status, including T81C-polymorphism, in a
central institution.
Study objective
Primary objective: To determine the antitumor activity regarding objective
response rate (ORR) of tipifarnib in subjects with locally advanced
non-resectable or metastatic, relapsed and/or refractory, non-haematological
malignancies with HRAS mutations.
Study design
A multi-centre, open-label phase II study.
Subjects will be enrolled in two non-randomised cohorts.
* Cohort 1: Malignant thyroid gland tumors with HRAS mutations.
* Cohort 2: Non-haematological malignancies with HRAS mutations in stage 1.
Squamous cell carcinomas in the head-neck area (SCCHN) with HRAS mutations in
stage 2.
* Cohort 3: Squamous cell carcinomas with HRAS mutations
Intervention
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 treatment with tipifarnib up to 12
months if there is no disease progression and unmanageable toxicity. The
treatment may continue for more than 12 months after approval of the
investigator and the sponsor.
Study burden and risks
There are certain risks and discomforts associated with study procedures.
There can be pain, swelling, and/or bruising at the site where blood is drawn
for lab assessments, as well as possible inflammation of the vein or an
infection at this site.
Mild skin rash (irritation, reddening or itching) can occur during an ECG at
places where electrodes are placed.
An imaging procedure may be uncomfotable and/or giving a claustrophobic
sensation and an injection with intravenous contrast may give itching, a rash,
hives, or a feeling of warmth throughout the body.
3033 Science Park Road Suite 220
San Diego CA92121
US
3033 Science Park Road Suite 220
San Diego CA92121
US
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201500453512-NL |
| CCMO | NL61057.042.17 |