A Phase I/II, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the MEK inhibitor WX-554 in patients with solid tumours

WILEX AG0 sites50 target enrollmentJanuary 5, 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available.
Sponsor: WILEX AG
Enrollment: 50
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

January 5, 2012

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. 18 years old or older.
•2\. Part 1 Dose Escalation: Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available.
•Part 2 Dose Expansion: Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available. Efforts will be made to enrol patients with tumours for which the MEK pathway is considered to play a significant role e.g. melanoma, thyroid, NSCLC, colon or pancreatic cancer.
•3\. Evaluable or measurable disease.
•4\. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2\.
•5\. Life expectancy of \>3 months, in the opinion of the Investigator.
•6\. Able to take oral medications.
•7\. Able to provide written informed consent.
•8\. Willing to provide consent for biomarker analysis of existing paraffin\-embedded tumour samples.
•9\. Laboratory parameters (obtained within the Screening period):

•1\. First WX\-554 administration planned within 4 weeks of receiving an investigational anti\-cancer drug.
•2\. Received major surgery, radiotherapy, or immunotherapy within 4 weeks of Cycle 1, Day 1\. Localised palliative radiotherapy is permitted for symptom control.
•3\. Received chemotherapy regimens with delayed toxicity within four weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle 1, Day 1\. Received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within two weeks of Cycle 1, Day 1\.
•4\. Clinically significant, unresolved toxicity from previous anti\-cancer therapy greater than Grade 1 (except alopecia), as determined by NCI CTCAE v4\.03 criteria.
•5\. Previously received a MEK inhibitor.
•6\. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
•7\. Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis.
•8\. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
•9\. Condition that in the Investigator's opinion would jeopardize compliance with the protocol.
•10\. Known HIV positivity or active hepatitis B or C infection.