A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors
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In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.
establish Maximum tolerate dose (MTD) [ Time Frame: every day up to first 4 weeks ]
Secondary Outcome Measures
Safety assessed by type, frequency and severity of adverse events [ Time Frame: Every week ]
Efficacy assessed by RECIST [ Time Frame: Every 2 months ]
Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples [ Time Frame: Every 2 weeks up to first 4 weeks, then every odd cycle ]
Measurement of biomarkers for PI3K pathway in blood and tissue [ Time Frame: First 4 weeks ]
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
Age ≥ 20 years
Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
Life expectancy of ≥ 12 weeks
Patients must have the laboratory values
Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
Prior treatment with a PI3K inhibitor
Patients with any peripheral neuropathy ≥ CTCAE grade 2
Patients with unresolved diarrhea ≥ CTCAE grade 2
Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment.
Other protocol-defined inclusion/exclusion criteria may apply