Advanced Solid Tumor
Conditions
Keywords
Pi3K, Advanced solid tumor
Brief summary
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.
Interventions
DRUGBYL719
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose | 4 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by type, frequency and severity of adverse events | 4 Months | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. |
| Efficacy assessed by RECIST | 4 months | 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 |
| To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2) | 4 months | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. |
| Levels of biomarkers in tumor and skin | 4 months | Patients may continue treatment with BYL719 until the patient experiences unacceptable toxicity or progressive disease, an expected average of 4 months. |
Countries
Japan
Outcome results
None listed