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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01501604
Eligibility Criteria:
Inclusion Criteria:
* At least 1 site of measurable disease
* Life expectancy \>/= 12 weeks
* Adequate marrow and organ function
* Diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer
* Pathologically documented, definitively diagnosed, advanced solid tuor that is refractory to standard treatment, for which no standard therapy is available, or the subject refuses standard therapy
* Cancer must have at least one of the following PIK3CA mutations: E542K, E545K, H1047R, H1047L. The PIK3CA mutation must be documented in a CLIA approved laboratory
Exclusion Criteria:
* Prior treatment with a P13K inhibitor
* Known hypersensitivity to BKM120 or its excipients
* Untreated brain metastases
* Acute or chronic liver, renal disease or pancreatitis
* Currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A
* Diarrhea \>/= CTCAE grade 2
* Any concurrent severe and/or uncontrolled medical condition
* Active cardiac disease
* History of cardiac dysfunction
* Poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
* Significant symptomatic deterioration of lung function
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKDM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
* Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
* Pregnant or breast-feeding
* Known diagnosis of HIV infection
* History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
* Unable to swallow the medication in its prescribed form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01501604
Study Brief:
Protocol Section:
NCT01501604