Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01859351
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01859351
Study Brief:
Protocol Section:
NCT01859351