A research study to evaluate the response rate of tipifarnib in patients with locally advanced unresectable or metastasic, relapsed and/or refractory, squamous non-small cell lung cancer with HRAS mutations

Phase 1

• Conditions: squamous non-small cell lung cancer (SQ-NSCLC); MedDRA version: 20.0 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004822-13-ES
• Lead Sponsor: Spanish Lung Cancer Group (SLCG/GECP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC) for which there is no curative therapy available.
- Relapsed of disease (progressive disease) or is refractory to one or more prior therapies. In the case of therapy received in the adjuvant or neo-adjuvant setting, relapse must have occurred within 12 months to be considered prior therapy.
- A tumor that carries a missense HRAS mutation.
- Consent to provide tumor slides (or tumor tissue blocks) for biomarker evaluation.
- Subject has measurable disease according to RECIST v1.1.
- At least 2 weeks since the last systemic therapy regimen prior to enrolment.
- At least 2 weeks since last radiotherapy. If radiation was localized to the only site of measurable disease, there must be documentation of disease progression of the irradiated site. Subjects must have recovered from all acute toxicities from radiotherapy.
- ECOG performance status of 0 or 1.
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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

- 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.
- The subject has legal incapacity or limited legal capacity.
- Significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.

Study & Design

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