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

NCT01449058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2017-10-02

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

BYL719

taken orally

DRUG

MEK162

taken orally

Sponsors & Collaborators

  • Array BioPharma

    lead INDUSTRY

Principal Investigators

  • Array BioPharma · 303-381-6604

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-08-31
Completion
2017-08-15

Countries

  • United States
  • Australia
  • France
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01449058 on ClinicalTrials.gov