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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: BEZ235


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. At least one measurable lesion as defined by RECIST criteria for solid tumors. Age ≥ 20 Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2 Life expectancy of ≥ 12 weeks 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. Availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening. 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: 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 Patients with any peripheral neuropathy ≥ CTCAE grade 2 Patients with unresolved diarrhea ≥ CTCAE grade 2 Patients with a history of photosensitivity reactions to other drugs 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEZ235 Dose Escalation once daily<br>oral BEZ235 once daily (q.d.) | Drug: BEZ235<br> <br> |
| Experimental: BEZ Dose escalation twice daily<br>oral BEZ235 twice daily (b.i.d.) | Drug: BEZ235<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish Maximum tolerate dose (MTD) |  | Every week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PI3K, mTOR, Advanced solid tumor