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A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

NCT ID: NCT01449058

Last Updated: 2017-10-02

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

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-08-15

Brief Summary

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This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.

Detailed Description

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Conditions

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Advanced and Selected Solid Tumors AML High Risk and Very High Risk MDS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BYL719 + MEK162

BYL719 plus MEK162. Dose escalation with a starting dose for the first cohort of 200mg QD BYL719 and 30mg BID MEK162

Group Type EXPERIMENTAL

BYL719

Intervention Type DRUG

taken orally

MEK162

Intervention Type DRUG

taken orally

Interventions

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BYL719

taken orally

Intervention Type DRUG

MEK162

taken orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
* Measurable disease as determined by RECIST 1.1

Exclusion Criteria

* Primary CNS tumor or CNS tumor involvement
* Diabetes mellitus
* Unacceptable ocular/retinal conditions
* Clinically significant cardiac disease or impaired cardiac function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Array BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Array BioPharma

Role: STUDY_DIRECTOR

303-381-6604

Locations

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University of California San Diego - Moores Cancer Center Dept Onc

La Jolla, California, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC

Tampa, Florida, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital CCPO

Boston, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center Onc. Dept

New York, New York, United States

Site Status

Montefiore Medical Center SC

The Bronx, New York, United States

Site Status

University of Texas/MD Anderson Cancer Center Dept. of Onc.

Houston, Texas, United States

Site Status

University of Utah / Huntsman Cancer Institute Huntsman (3)

Salt Lake City, Utah, United States

Site Status

Array BioPharma Investigative Site

Parkville, Victoria, Australia

Site Status

Array BioPharma Investigative Site

Villejuif, , France

Site Status

Array BioPharma Investigative Site

Milan, MI, Italy

Site Status

Array BioPharma Investigative Site

Roma, RM, Italy

Site Status

Array BioPharma Investigative Site

Barcelona, Catalonia, Spain

Site Status

Array BioPharma Investigative Site

Barcelona, Catalonia, Spain

Site Status

Array BioPharma Investigative Site

Bellinzona, , Switzerland

Site Status

Array BioPharma Investigative Site

Sutton, , United Kingdom

Site Status

Countries

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United States Australia France Italy Spain Switzerland United Kingdom

Other Identifiers

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2011-002578-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMEK162X2109

Identifier Type: -

Identifier Source: org_study_id