Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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 : December 9, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: BEZ235 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
Study Start Date : October 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: BEZ235 Dose Escalation once daily
oral BEZ235 once daily (q.d.)
Drug: BEZ235
Experimental: BEZ Dose escalation twice daily
oral BEZ235 twice daily (b.i.d.)
Drug: BEZ235

Primary Outcome Measures :
  1. To establish Maximum tolerate dose (MTD) [ Time Frame: Every week ]

Secondary Outcome Measures :
  1. Safety assessed by type, frequency and severity of adverse events [ Time Frame: Every week ]
  2. Efficacy assessed by RECIST [ Time Frame: Every 2 months ]
  3. To characterize the PK profiles [ Time Frame: Every 2 weeks ]
  4. To assess the biomarkers [ Time Frame: Every 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01195376

Layout table for location information
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site
Yufu, Oita, Japan, 879-5593
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01195376    
Other Study ID Numbers: CBEZ235A1101
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: April 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced solid tumor
Additional relevant MeSH terms:
Layout table for MeSH terms
Antineoplastic Agents