A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Advanced Solid Tumor Clinical Trial

Official title:

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387321
• Other study ID #: CBYL719X1101
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2011
• Est. completion date: November 25, 2015

Study information

• Verified date: August 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 25, 2015
• Est. primary completion date: November 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BYL719

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Koto-ku	Tokyo
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		4 Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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