A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Study Overview
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Brief Summary
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In this study, BYL719 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 investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.

Official Title
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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: BYL719


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically-confirmed, advanced unresectable solid tumors Availability of a representative formalin fixed paraffin embedded tumor tissue sample At least one measurable or non-measurable lesion Age ≥ 18 years Eastern Cooperative Oncology Group(ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit Exclusion Criteria: Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy. Prior treatment with PI3K inhibitor Patient with peripheral neuropathy NCI-CTC Grade ≥ 2 Patient with diarrhea NCI-CTC Grade ≥ 2 Patient with acute or chronic pancreatitis Impaired cardiac function or clinically significant cardiac disease incl unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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: BYL719<br> | Drug: BYL719<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose |  | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by type, frequency and severity of adverse events | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. | 4 Months | 
| Efficacy assessed by RECIST | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. RECIST - Response Evaluation Criteria In Solid Tumors | 4 months | 
| To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2) | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. | 4 months | 
| Levels of biomarkers in tumor and skin | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pi3K, Advanced solid tumor