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A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors

Phase 1
20 Years
Open (Enrolling)
Advanced Solid Tumor

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Trial Information

A Phase I Study of BEZ235, 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 lesion as defined by RECIST criteria for solid tumors.

3. Age ≥ 20

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 Patients in the expansion part of this study
have to meet the following criteria in addition to the criteria described above.

7. Availability of a representative tumor tissue specimen (either archival tumor or
fresh tumor biopsy) for pre-screening.

8. Patients whose molecular status proved to meet the criteria (PIK3CA
mutation/amplification and/or PTEN mutation and/or low/null PTEN expression) during

Exclusion Criteria:

1. Patients who have brain metastases or who have signs/symptoms attributable and have
not been assessed with radiologic imaging to rule out the presence of brain

2. Patients with any peripheral neuropathy ≥ CTCAE grade 2

3. Patients with unresolved diarrhea ≥ CTCAE grade 2

4. Patients with a history of photosensitivity reactions to other drugs

5. Women of child-bearing potential who are pregnant or breast feeding or adults of
reproductive potential not employing an effective method of birth control. Barrier
contraceptives must be used throughout the trial in both sexes. Women of
child-bearing potential, defined as sexually mature women who have not undergone a
hysterectomy or who have not been naturally postmenopausal for at least consecutive 1
years (i.e., who has had menses any time in the preceding consecutive 2 years), must
have a negative serum pregnancy test ≤ 7 days prior to starting BEZ235.

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:

To establish Maximum tolerate dose (MTD)

Outcome Time Frame:

Every week

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 2010

Completion Date:

May 2013

Related Keywords:

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