Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

NCT ID: NCT01363232

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-12-18

Brief Summary

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.

Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.

Conditions

Advanced Solid Tumors; Selected Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BKM120 + MEK162

Group Type: EXPERIMENTAL

BKM120 + MEK162

Intervention Type: DRUG

Interventions

BKM120 + MEK162

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically/ cytologically confirmed, advanced non resectable solid tumors
• Measurable or non-measurable, but evaluable disease as determined by RECIST

Exclusion Criteria

• Patients with primary CNS tumor or CNS tumor involvement.
• Diabetes mellitus
• Unacceptable ocular/retinal conditions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

1-800-718-1021

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Massachusetts General Hospital Mass General 2

Boston, Massachusetts, United States

Karmanos Cancer Institute Study Coordinator

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center MSKCC (2)

New York, New York, United States

Cancer Centers of the Carolinas CCC Faris

Greenville, South Carolina, United States

University of Texas/MD Anderson Cancer Center MD Anderson PSC

Houston, Texas, United States

Pfizer Investigative Site

Toronto, Ontario, Canada

Pfizer Investigative Site

Essen, , Germany

Pfizer Investigative Site

Heidelberg, , Germany

Pfizer Investigative Site

Utrecht, , Netherlands

Pfizer Investigative Site

Singapore, , Singapore

Pfizer Investigative Site

Barcelona, Catalonia, Spain

Pfizer Investigative Site

Bellinzona, , Switzerland

Countries

United States; Canada; Germany; Netherlands; Singapore; Spain; Switzerland

References

Bardia A, Gounder M, Rodon J, Janku F, Lolkema MP, Stephenson JJ, Bedard PL, Schuler M, Sessa C, LoRusso P, Thomas M, Maacke H, Evans H, Sun Y, Tan DSW. Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. Oncologist. 2020 Jan;25(1):e160-e169. doi: 10.1634/theoncologist.2019-0297. Epub 2019 Aug 8.

Reference Type: DERIVED

PMID: 31395751 (View on PubMed)

Other Identifiers

2011-001083-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMEK162X2101

Identifier Type: -

Identifier Source: org_study_id