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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01195376
First received: September 2, 2010
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Advanced Solid Tumor
Drug: BEZ235
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To establish Maximum tolerate dose (MTD) [ Time Frame: Every week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety assessed by type, frequency and severity of adverse events [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
  • Efficacy assessed by RECIST [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • To characterize the PK profiles [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
  • To assess the biomarkers [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195376

Locations
Japan
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site
Yufu, Oita, Japan, 879-5593
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01195376     History of Changes
Other Study ID Numbers: CBEZ235A1101
Study First Received: September 2, 2010
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
PI3K
mTOR
Advanced solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014