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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumours

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WX-554

Group Type EXPERIMENTAL

WX-554

Intervention Type DRUG

Capsules of WX-554

Interventions

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WX-554

Capsules of WX-554

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No