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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BEZ235

• Registration Number: NCT01195376
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Study Start: 2010-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEZ235 Dose Escalation once daily	BEZ235	oral BEZ235 once daily (q.d.)
BEZ Dose escalation twice daily	BEZ235	oral BEZ235 twice daily (b.i.d.)

Primary Outcome Measures

Name	Time	Method
To establish Maximum tolerate dose (MTD)	Every week

Secondary Outcome Measures

Name	Time	Method
Safety assessed by type, frequency and severity of adverse events	Every week
Efficacy assessed by RECIST	Every 2 months
To characterize the PK profiles	Every 2 weeks
To assess the biomarkers	Every 2 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Yufu, Oita, Japan