A Phase I/II study of WX-554 in solid tumours
- Conditions
- Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available.Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864
- Registration Number
- EUCTR2011-003408-19-GB
- Lead Sponsor
- WILEX AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
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):
• Absolute neutrophils count =1.5x10E9/L;
• Platelets =100 x10E9/L;
• Haemoglobin =9 g/dL;
• Total bilirubin =1.5 x ULN;
• AST/ALT = 2.5 x ULN (if liver metastases are present, =5 x ULN);
• AP = 2.5 x ULN (if bone metastases are present, =5 x ULN;
• Serum creatinine =1.5 x ULN or estimated GFR of >50 mL/min based on the Wright formula .
10. Negative hCG test in women of childbearing potential (defined as women =50 years of age or history of amenorrhea for =12 months prior to study entry). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 1 month after final administration of WX-554, or the patient must be surgically sterile (with documentation in the patient’s medical records).
11. If there is a history of treated brain metastases, these must have been clinically stable for =4 weeks prior to enrollment. Steroid treatment must also be a stable or reducing dose during this time period.
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 20
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.
11. History of clinically significant cardiac condition, including ischaemic cardiac event or myocardial infarction within 6 months, or unstable cardiac disease within 3 months of Cycle 1, Day 1.
12. History of significant chronic or (re)current infection or intercurrent illness that could jeopardise patient safety, interfere with the objectives of the protocol or limit patient compliance with the study procedures, as determined by the Investigator.
13. Pregnant or lactating female.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method