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

Heidelberg Pharma

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumours

Treatments: Drug: WX-554; Drug: WX-037

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859351

2012-004552-11 (EudraCT Number)

WX/90-001

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

WX-037

Experimental group

Description:

PI3K inhibitor

Treatment:

Drug: WX-037

WX-037 in combination with WX-554

Experimental group

Description:

PI3K inhibitor in combination with MEK inhibitor

Treatment:

Drug: WX-037

Drug: WX-554