A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
Inclusion Criteria:
1. 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.
2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for
solid tumors.
3. Age ≥ 20 years
4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
5. Life expectancy of ≥ 12 weeks
6. Patients must have the laboratory values
Exclusion Criteria:
1. 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
2. Prior treatment with a PI3K inhibitor
3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
4. Patients with unresolved diarrhea ≥ CTCAE grade 2
5. 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