A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
1 other identifier
interventional
33
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2011
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
July 4, 2011
CompletedStudy Start
First participant enrolled
September 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2015
CompletedDecember 8, 2020
August 1, 2018
4.2 years
June 27, 2011
December 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose
4 Weeks
Secondary Outcomes (4)
Safety assessed by type, frequency and severity of adverse events
4 Months
Efficacy assessed by RECIST
4 months
To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2)
4 months
Levels of biomarkers in tumor and skin
4 months
Study Arms (1)
BYL719
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Novartis Investigative Site
Nagoya, Aichi-ken, 460-0001, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 466 8560, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045, Japan
Novartis Investigative Site
Koto-ku, Tokyo, 135 8550, Japan
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2011
First Posted
July 4, 2011
Study Start
September 22, 2011
Primary Completion
November 25, 2015
Study Completion
November 25, 2015
Last Updated
December 8, 2020
Record last verified: 2018-08