- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387321
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies
December 6, 2020 updated by: Novartis Pharmaceuticals
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
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Nagoya, Aichi, Japan, 466 8560
- Novartis Investigative Site
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Nagoya, Aichi, Japan, 460-0001
- Novartis Investigative Site
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- Novartis Investigative Site
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Koto-ku, Tokyo, Japan, 135 8550
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BYL719
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose
Time Frame: 4 Weeks
|
4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessed by type, frequency and severity of adverse events
Time Frame: 4 Months
|
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
Time Frame: 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 |
4 months
|
To characterize the PK Profiles (AUC, Cmax, Tmax, CL/F, Vz/F, T1/2)
Time Frame: 4 months
|
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
Time Frame: 4 months
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBYL719X1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novartis PharmaceuticalsCompletedRelapsed and Refractory Multiple MyelomaItaly, Germany, Singapore, Australia, United States
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Array BioPharmaCompletedAML | Advanced and Selected Solid Tumors | High Risk and Very High Risk MDSUnited States, Australia, Italy, Spain, France, Switzerland, United Kingdom
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Novartis PharmaceuticalsTerminatedRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell CarcinomaFrance, Taiwan, United States, Australia, Canada, Hong Kong, Singapore, Korea, Republic of, Netherlands