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A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors

Phase 1
20 Years
Not Enrolling
Advanced Solid Tumor

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Trial Information

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

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

establish Maximum tolerate dose (MTD)

Outcome Time Frame:

every day up to first 4 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Advanced Solid Tumor
  • PI3K,
  • Advanced solid tumor
  • Neoplasms