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

Array BioPharma

Status and phase: Completed; Phase 1

Conditions: AML; Advanced and Selected Solid Tumors; High Risk and Very High Risk MDS

Treatments: Drug: MEK162; Drug: BYL719

Study type: Interventional

Funder types: Industry

Identifiers

NCT01449058

2011-002578-21 (EudraCT Number)

CMEK162X2109

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

BYL719 + MEK162

Experimental group

Description:

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

Treatment:

Drug: MEK162

Drug: BYL719