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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01449058




Registration number
NCT01449058
Ethics application status
Date submitted
6/10/2011
Date registered
7/10/2011
Date last updated
2/10/2017

Titles & IDs
Public title
A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
Scientific title
A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
Secondary ID [1] 0 0
2011-002578-21
Secondary ID [2] 0 0
CMEK162X2109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced and Selected Solid Tumors 0 0
AML 0 0
High Risk and Very High Risk MDS 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BYL719
Treatment: Drugs - MEK162

Experimental: BYL719 + MEK162 - BYL719 plus MEK162. Dose escalation with a starting dose for the first cohort of 200mg QD BYL719 and 30mg BID MEK162


Treatment: Drugs: BYL719
taken orally

Treatment: Drugs: MEK162
taken orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
during the first cycle (28 days) of treatment with BYL719 and MEK162
Secondary outcome [1] 0 0
Number of participants with adverse events and serious adverse events
Timepoint [1] 0 0
Assessed from Cycle 1 Day 1 until treatment discontinuation
Secondary outcome [2] 0 0
Overall response rate
Timepoint [2] 0 0
Assessed every 8 weeks until disease progression
Secondary outcome [3] 0 0
Time to progression
Timepoint [3] 0 0
Assessed every 8 weeks until disease progression
Secondary outcome [4] 0 0
Progression free survival
Timepoint [4] 0 0
Assessed every 8 weeks until disease progression
Secondary outcome [5] 0 0
Time versus plasma concentration profiles of BYL719 and MEK162
Timepoint [5] 0 0
Assessed during the first cycle of treatment
Secondary outcome [6] 0 0
Correlation of baseline mutation or amplification status (PIK3CA, KRAS, NRAS and BRAF) and clinical anti-tumor activity outcome
Timepoint [6] 0 0
Assessed at Baseline (pre-treatment)
Secondary outcome [7] 0 0
Clinical benefit rate
Timepoint [7] 0 0
Assessed every 4 weeks for 3 months and every 3 months for 6 months followed by every 6 months thereafter until disease progression

Eligibility
Key inclusion criteria
* Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
* Measurable disease as determined by RECIST 1.1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary CNS tumor or CNS tumor involvement
* Diabetes mellitus
* Unacceptable ocular/retinal conditions
* Clinically significant cardiac disease or impaired cardiac function

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2017
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Array BioPharma 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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
France
State/province [8] 0 0
Villejuif Cedex
Country [9] 0 0
Italy
State/province [9] 0 0
MI
Country [10] 0 0
Italy
State/province [10] 0 0
RM
Country [11] 0 0
Spain
State/province [11] 0 0
Catalunya
Country [12] 0 0
Switzerland
State/province [12] 0 0
Bellinzona
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01449058