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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01363232
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
Array BioPharma ( Array Biopharma, now a wholly owned subsidiary of Pfizer )

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Selected Solid Tumors Drug: BKM120 + MEK162 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BKM120 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
Study Start Date : August 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 18, 2017

Arm Intervention/treatment
Experimental: BKM120 + MEK162 Drug: BKM120 + MEK162

Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities [ Time Frame: during Cycle 1 of treatment with BKM120 and MEK162 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events and serious adverse events. [ Time Frame: from Cycle 1 Day 1 until treatment discontinuation ]
  2. Overall response rate, duration of response, time to response and progression free survival [ Time Frame: every 8 weeks of treatment ]
  3. Time versus plasma concentration profiles of BKM120 and MEK162 [ Time Frame: during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15 ]
  4. Treatment -induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor. [ Time Frame: during the first cycle of treatment on Cycle 1 Day 15 and at disease progression ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01363232

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United States, Massachusetts
Massachusetts General Hospital Mass General 2
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Institute Study Coordinator
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan Kettering Cancer Center MSKCC (2)
New York, New York, United States, 90033
United States, South Carolina
Cancer Centers of the Carolinas CCC Faris
Greenville, South Carolina, United States, 29605
United States, Texas
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States, 77030-4009
Canada, Ontario
Pfizer Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Pfizer Investigative Site
Essen, Germany, 45147
Pfizer Investigative Site
Heidelberg, Germany, 69120
Pfizer Investigative Site
Utrecht, Netherlands, 3584CX
Pfizer Investigative Site
Singapore, Singapore, 169610
Pfizer Investigative Site
Barcelona, Catalunya, Spain, 08035
Pfizer Investigative Site
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
Array Biopharma, now a wholly owned subsidiary of Pfizer
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Study Director: Pfizer Call Center 1-800-718-1021
Study Director: Pfizer Call Center Pfizer
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Array Biopharma, now a wholly owned subsidiary of Pfizer Identifier: NCT01363232    
Other Study ID Numbers: CMEK162X2101
2011-001083-22 ( EudraCT Number )
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Keywords provided by Array BioPharma ( Array Biopharma, now a wholly owned subsidiary of Pfizer ):
RAS RAF mutations
triple negative breast cancer
pancreatic cancer, ovarian cancer
NSCLC progressed on EGFR TKI
PI3K inhibitor
MEK inhibitor
Additional relevant MeSH terms:
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