Phase I Study of WX-037 Alone and in Combination With WX-554 in 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

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to test the safety of escalating doses of the novel PI3K inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth.

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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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WX-037

PI3K inhibitor

Group Type EXPERIMENTAL

WX-037

Intervention Type DRUG

WX-037 in combination with WX-554

PI3K inhibitor in combination with MEK inhibitor

Group Type EXPERIMENTAL

WX-037

Intervention Type DRUG

WX-554

Intervention Type DRUG

Interventions

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WX-037

Intervention Type DRUG

WX-554

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced, metastatic and/or progressive solid tumors for whom there is no effective standard therapy available (for part 2 in addition patients for whom their PI3K pathway is deregulated)
* Evaluable or measurable disease
* Has normal organ function; is no greater than 2 on the ECOG performance scale
* Negative hCG test in women of childbearing potential

Exclusion Criteria

* History of diabetes requiring daily medication or history of grade 3 or more fasting hyperglycemia
* Patients with major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study
* Clinical significant, unresolved toxicity from previous anti-cancer therapy
* Patients who previously received a MEK inhibitor (for combination part only)
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs
* Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis (combination part only)
* Known HIV positivity or active hepatitis B or C infection
* History of clinically significant cardiac condition

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No