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Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

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ClinicalTrials.gov Identifier: NCT01337765
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

April 2, 2011
April 19, 2011
February 12, 2016
July 2011
March 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01337765 on ClinicalTrials.gov Archive Site
  • 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
  • Overall response rate, duration of response, time to response and progression free survival [ Time Frame: every 8 weeks of treatment ]
  • 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
  • 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
  • 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
  • Overall response rate, duration of response, time to response and progression free survival [ Time Frame: every 8 weeks of treatment ]
  • 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
  • Treatment-induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor and skin [ 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
  • Molecular status (genetic alterations, protein expression and/or activation) of markers related to PI3K and ERK signaling in tumor tissue and blood and their potential relationship to clinical responses. [ Time Frame: at baseline (pre-treatment) ]
Not Provided
Not Provided
 
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Solid Tumor
Drug: BEZ235 + MEK162
Experimental: BEZ235 + MEK162
Intervention: Drug: BEZ235 + MEK162
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
55
March 2013
March 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   France,   Spain,   United States
Germany
 
NCT01337765
CMEK162X2103
2011-000421-74 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Array BioPharma
Array BioPharma
Not Provided
Study Director: Array BioPharma 303-381-6604
Array BioPharma
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP