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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

NCT ID: NCT01387321

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-22

Study Completion Date

2015-11-25

Brief Summary

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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

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Conditions

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Advanced Solid Tumor

Keywords

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Pi3K Advanced solid tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BYL719

Group Type EXPERIMENTAL

BYL719

Intervention Type DRUG

Interventions

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BYL719

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Koto-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15347

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

Other Identifiers

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CBYL719X1101

Identifier Type: -

Identifier Source: org_study_id