A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01195376
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

September 2, 2010
September 6, 2010
April 21, 2016
October 2010
July 2013   (Final data collection date for primary outcome measure)
To establish Maximum tolerate dose (MTD) [ Time Frame: Every week ]
Same as current
Complete list of historical versions of study NCT01195376 on Archive Site
  • Safety assessed by type, frequency and severity of adverse events [ Time Frame: Every week ]
  • Efficacy assessed by RECIST [ Time Frame: Every 2 months ]
  • To characterize the PK profiles [ Time Frame: Every 2 weeks ]
  • To assess the biomarkers [ Time Frame: Every 2 months ]
Same as current
Not Provided
Not Provided
A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors
A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
In this study, BEZ235 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 confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumor
Drug: BEZ235
  • Experimental: BEZ235 Dose Escalation once daily
    oral BEZ235 once daily (q.d.)
    Intervention: Drug: BEZ235
  • Experimental: BEZ Dose escalation twice daily
    oral BEZ235 twice daily (b.i.d.)
    Intervention: Drug: BEZ235
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2013
July 2013   (Final data collection date for primary outcome measure)

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 pre-screening.

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 metastases
  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

Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP