Phase I/II Dose-escalation Study to Investigate Safety and Pharmacokinetics/ Pharmacodynamics of WX-554 in Patients With Solid Tumours

Heidelberg Pharma

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Solid Tumours

Treatments: Drug: WX-554

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581060

WX/80-003

2011-003408-19 (EudraCT Number)

Details and patient eligibility

About

The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of chronic treatment with WX-554.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available.
2. Evaluable or measurable disease
3. Has normal organ functions; is no greater than 2 on the ECOG Performance Scale
4. life expectancy of >3 months
5. negative hCG test in women of childbearing potential

Exclusion criteria

1. Patients who received an investigational anti-cancer drug within 4 weeks of starting the study
2. Patients who received major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study
3. Clinically significant, unresolved toxicity from previous anti-cancer therapy Patients
4. Patients who previously received a MEK inhibitor
5. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
6. Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis.
7. Known HIV positivity or active hepatitis B or C infection.
8. History of clinically significant cardiac condition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 1 patient group

WX-554

Experimental group

Treatment:

Drug: WX-554