A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BYL719

• Registration Number: NCT01387321
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-04
• Study Start: 2011-09-22
• Primary Completion: 2015-11-25
• Study Completion: 2015-11-25
• Status Verified: 2018-08
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BYL719	BYL719	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	4 Weeks

Secondary Outcome Measures

Name	Time	Method
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
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.
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Koto-ku, Tokyo, Japan