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Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 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.
 
ClinicalTrials.gov Identifier: NCT01337765
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant 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 BEZ235 and MEK162.

Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Solid Tumor Drug: BEZ235 + MEK162 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 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 BEZ235 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
Actual Study Start Date : July 8, 2011
Actual Primary Completion Date : March 22, 2013
Actual Study Completion Date : March 22, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Binimetinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: BEZ235 + MEK162 Drug: BEZ235 + MEK162


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities [ Time Frame: during Cycle 1 of treatment with BEZ235 and MEK162 ]
    A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination


Secondary Outcome Measures :
  1. Number of participants with adverse events and serious adverse events [ Time Frame: from Cycle 1 Day 1 until treatment discontinuation ]
    A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination

  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 BEZ235 and MEK162 [ Time Frame: during the first cycle of treatment ]
    A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination

  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 and at disease progression ]
    A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination


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

Inclusion Criteria:

  • histologically/cytologically confirmed, advanced non resectable solid tumors
  • Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01337765


Locations
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United States, Massachusetts
Massachusetts General Hospital Mass General 2
Boston, Massachusetts, United States, 02114
United States, Texas
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States, 77030-4009
Australia, Victoria
Pfizer Investigative Site
Parkville, Victoria, Australia, 3050
Canada, Ontario
Pfizer Investigative Site
Toronto, Ontario, Canada, M5G 2M9
France
Pfizer Investigative Site
Villejuif Cedex, France, 94805
Spain
Pfizer Investigative Site
Barcelona, Cataluña, Spain, 08035
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01337765    
Other Study ID Numbers: CMEK162X2103
2011-000421-74 ( EudraCT Number )
C4211009 ( Other Identifier: Pfizer )
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
BEZ235,
MEK162
RAS RAF mutations,
triple negative breast cancer
pancreatic cancer,
 NSCLC progressed on EGFR TKI
PI3K/mTOR inhibitor,
MEK inhibitor
Advanced and selected solid tumors
Additional relevant MeSH terms:
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Neoplasms
Dactolisib
Antineoplastic Agents