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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg Pharma AG; Wilex

Criteria

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