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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195376
• Other study ID #: CBEZ235A1101
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Est. completion date: July 2013

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BEZ235

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish Maximum tolerate dose (MTD)		Every week
Secondary	Safety assessed by type, frequency and severity of adverse events		Every week
Secondary	Efficacy assessed by RECIST		Every 2 months
Secondary	To characterize the PK profiles		Every 2 weeks
Secondary	To assess the biomarkers		Every 2 months

External Links

•   Results for CBEZ235A1101 can be found on the Novartis Clinical Trial Results Website