A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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In this study, BKM120 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 confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.

Official Title
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A Phase I Study of BKM120, 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: BKM120


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 or non-measurable lesion as defined by RECIST guidelines for solid tumors. Age ≥ 20 years Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2 Life expectancy of ≥ 12 weeks Patients must have the laboratory values Exclusion Criteria: Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases Prior treatment with a PI3K inhibitor Patients with any peripheral neuropathy ≥ CTCAE grade 2 Patients with unresolved diarrhea ≥ CTCAE grade 2 Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BKM120<br> | Drug: BKM120<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| establish Maximum tolerate dose (MTD) |  | every day up to first 4 weeks | 

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 | 
| Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples |  | Every 2 weeks up to first 4 weeks, then every odd cycle | 
| Measurement of biomarkers for PI3K pathway in blood and tissue |  | First 4 weeks | 

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