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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2011-002578-21
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Secondary ID [2]
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CMEK162X2109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced and Selected Solid Tumors
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AML
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High Risk and Very High Risk MDS
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Dose Limiting Toxicities (DLT)
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Assessment method [1]
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Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 unless otherwise specified. A DLT is defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, occurs = 28 days following the first dose of BYL719 and MEK162 (Cycle 1), and meets any of the protocol-specified DLT criteria.
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Timepoint [1]
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during the first cycle (28 days) of treatment with BYL719 and MEK162
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Secondary outcome [1]
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Number of participants with adverse events and serious adverse events
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Assessment method [1]
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All AEs and SAEs will be collected in accordance with the protocol and assessed for relatedness to study drug combination.
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Timepoint [1]
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Assessed from Cycle 1 Day 1 until treatment discontinuation
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Secondary outcome [2]
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Overall response rate
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Assessment method [2]
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Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR).
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Timepoint [2]
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Assessed every 8 weeks until disease progression
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Secondary outcome [3]
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Time to progression
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Assessment method [3]
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Time to progression (TTP) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient has not had an event, time to progression is censored at the date of last adequate tumor assessment.
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Timepoint [3]
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Assessed every 8 weeks until disease progression
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Secondary outcome [4]
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Progression free survival
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Assessment method [4]
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Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.
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Timepoint [4]
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Assessed every 8 weeks until disease progression
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Secondary outcome [5]
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Time versus plasma concentration profiles of BYL719 and MEK162
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Assessment method [5]
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Blood concentrations of MEK162 and its metabolite (AR00426032) and BYL719 will be assessed during the first cycle of treatment.
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Timepoint [5]
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Assessed during the first cycle of treatment
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Secondary outcome [6]
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Correlation of baseline mutation or amplification status (PIK3CA, KRAS, NRAS and BRAF) and clinical anti-tumor activity outcome
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Assessment method [6]
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Collect baseline genetic mutation/alteration status to investigate the potential relationship to anti-tumor activity.
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Timepoint [6]
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Assessed at Baseline (pre-treatment)
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Secondary outcome [7]
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Clinical benefit rate
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Assessment method [7]
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The clinical benefit rate is defined as the proportion of patients with complete remission, complete remission with incomplete blood count recovery, partial remission, minor response or stable disease for > 15 weeks
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Timepoint [7]
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Assessed every 4 weeks for 3 months and every 3 months for 6 months followed by every 6 months thereafter until disease progression
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Primary CNS tumor or CNS tumor involvement
- Diabetes mellitus
- Unacceptable ocular/retinal conditions
- Clinically significant cardiac disease or impaired cardiac function
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/08/2017
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Sample size
Target
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Accrual to date
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Final
139
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Array BioPharma Investigative Site - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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United States of America
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State/province [7]
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Utah
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Country [8]
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France
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State/province [8]
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Villejuif Cedex
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Country [9]
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Italy
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State/province [9]
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MI
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Country [10]
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Italy
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State/province [10]
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RM
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Country [11]
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Spain
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State/province [11]
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Catalunya
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Country [12]
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Switzerland
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State/province [12]
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Bellinzona
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Country [13]
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United Kingdom
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State/province [13]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Array BioPharma
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum
tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally
administered combination of BYL719 and MEK162. This combination will be explored in adult
patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or
other advanced solid tumors and in adult patients with AML or high risk and very high risk
MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian
logistic regression model with overdose control. At MTD or RDE, four expansion arms will be
opened in order to further assess the safety and preliminary activity of the combination of
BYL719 and MEK162 in specific patient populations.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01449058
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Array BioPharma
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Address
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303-381-6604
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01449058
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