A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BYL719

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 466 8560
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 460-0001
      • Novartis Investigative Site
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Novartis Investigative Site
    • Koto-ku, Tokyo, Japan, 135 8550
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BYL719	Drug: BYL719

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CBYL719X1101 can be found on the Novartis Clinical Trials Results Website

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2011
• Primary Completion (Actual): November 25, 2015
• Study Completion (Actual): November 25, 2015

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Advanced solid tumor; Pi3K
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CBYL719X1101