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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01337765




Registration number
NCT01337765
Ethics application status
Date submitted
2/04/2011
Date registered
19/04/2011
Date last updated
12/02/2016

Titles & IDs
Public title
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients
Scientific 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
Secondary ID [1] 0 0
2011-000421-74
Secondary ID [2] 0 0
CMEK162X2103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified Adult Solid Tumor, Protocol Specific 0 0
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BEZ235 + MEK162

Experimental: BEZ235 + MEK162 -


Treatment: Drugs: BEZ235 + MEK162


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities - A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Timepoint [1] 0 0
during Cycle 1 of treatment with BEZ235 and MEK162
Secondary outcome [1] 0 0
Number of participants with adverse events and serious adverse events - A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Timepoint [1] 0 0
from Cycle 1 Day 1 until treatment discontinuation
Secondary outcome [2] 0 0
Overall response rate, duration of response, time to response and progression free survival
Timepoint [2] 0 0
every 8 weeks of treatment
Secondary outcome [3] 0 0
Time versus plasma concentration profiles of BEZ235 and MEK162 - A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Timepoint [3] 0 0
during the first cycle of treatment
Secondary outcome [4] 0 0
Treatment-induced PI3K and MEK/ERK pathway signaling inhibition and evidence of biological activity in tumor - A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination
Timepoint [4] 0 0
during the first cycle of treatment and at disease progression

Eligibility
Key inclusion criteria
- histologically/cytologically confirmed, advanced non resectable solid tumors

- Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
France
State/province [4] 0 0
Villejuif Cedex
Country [5] 0 0
Spain
State/province [5] 0 0
Cataluña

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Array BioPharma
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01337765
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Array BioPharma
Address 0 0
303-381-6604
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications