Status:
TERMINATED
Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours
Lead Sponsor:
Heidelberg Pharma AG
Conditions:
Advanced Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 prote...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01859351
Start Date
July 1 2013
End Date
April 1 2014
Last Update
May 16 2014
Active Locations (3)
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1
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
2
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
3
Guy's and St Thomas' Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT