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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02159066




Registration number
NCT02159066
Ethics application status
Date submitted
28/04/2014
Date registered
9/06/2014

Titles & IDs
Public title
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
Scientific title
The LOGIC 2 Trial A Phase II, Multi-center, Open-label Study of Sequential LGX818/MEK162 Combination Followed by a Rational Combination With Targeted Agents After Progression, to Overcome Resistance in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma.
Secondary ID [1] 0 0
C4221013
Secondary ID [2] 0 0
CLGX818X2109
Universal Trial Number (UTN)
Trial acronym
LOGIC-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LGX818
Treatment: Drugs - MEK162
Treatment: Drugs - LEE011
Treatment: Drugs - BGJ398
Treatment: Drugs - BKM120
Treatment: Drugs - INC280

Experimental: LGX818 + MEK162 -

Experimental: LGX818 + MEK162 + LEE011 -

Experimental: LGX818 + MEK162 + BGJ398 -

Experimental: LGX818 + MEK162 + BKM120 -

Experimental: LGX818 + MEK162 + INC280 -


Treatment: Drugs: LGX818
Combination of LGX818 and MEK162 (Part I)

Treatment: Drugs: MEK162
Combination of LGX818 and MEK162 (Part I)

Treatment: Drugs: LEE011
Combination of LGX818 + MEK162 + LEE011 (Part II)

Treatment: Drugs: BGJ398
Combination of LGX818 + MEK162 + BGJ398 (Part II)

Treatment: Drugs: BKM120
Combination of LGX818 + MEK162 + BKM120 (Part II)

Treatment: Drugs: INC280
Combination of LGX818 + MEK162 + INC280 (Part II)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR): Part II
Timepoint [1] 0 0
From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs) in Cycle 1: Part II
Timepoint [1] 0 0
Cycle 1 (21 days following the first dose of the combination treatment with buparlisib and capmatinib; 28 days for the combination with ribociclib and infigratinib)
Secondary outcome [2] 0 0
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Part I
Timepoint [2] 0 0
Day 1 up to 30 days after last dose (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [3] 0 0
Number of Participants With AEs and SAEs: Part II
Timepoint [3] 0 0
Day 1 up to 30 days after last dose (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [4] 0 0
Number of Participants With Worst Post-baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade: Part I
Timepoint [4] 0 0
Baseline up to last dose (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [5] 0 0
Number of Participants With Worst Post-baseline Hematology Results Based on CTCAE v4.03 Grade: Part II
Timepoint [5] 0 0
Baseline up to last dose (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [6] 0 0
Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part I
Timepoint [6] 0 0
Baseline up to last dose (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [7] 0 0
Number of Participants With Worst Post-baseline Serum Chemistry Results Based on CTCAE v4.03 Grade: Part II
Timepoint [7] 0 0
Baseline up to last dose (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [8] 0 0
Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part I
Timepoint [8] 0 0
During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [9] 0 0
Number of Participants With Newly Occurring Notably Abnormal Vital Signs: Part II
Timepoint [9] 0 0
During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [10] 0 0
Number of Participants With Notable Electrocardiograms (ECG) Values: Part I
Timepoint [10] 0 0
During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [11] 0 0
Number of Participants With Notable ECG Values: Part II
Timepoint [11] 0 0
During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [12] 0 0
Number of Participants With At Least One Dose Interruption: Part I
Timepoint [12] 0 0
During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [13] 0 0
Number of Participants With At Least One Dose Interruption: Part II
Timepoint [13] 0 0
During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [14] 0 0
Number of Participants With At Least One Dose Reduction: Part I
Timepoint [14] 0 0
During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [15] 0 0
Number of Participants With At Least One Dose Reduction: Part II
Timepoint [15] 0 0
During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [16] 0 0
Actual Dose Intensity: Part I
Timepoint [16] 0 0
During study treatment (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [17] 0 0
Actual Dose Intensity: Part II
Timepoint [17] 0 0
During study treatment (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [18] 0 0
Progression-Free Survival (PFS): Part I
Timepoint [18] 0 0
From start of study drug until documented PD or death due to any cause or censoring date (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [19] 0 0
PFS: Part II
Timepoint [19] 0 0
From start of study drug until documented PD or death due to any cause or censoring date (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [20] 0 0
Duration of Response (DOR): Part I
Timepoint [20] 0 0
From date of first documented response (CR or PR) till the date of first documented progression or death due to underlying cancer or censoring date (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [21] 0 0
DOR: Part II
Timepoint [21] 0 0
From date of first documented response (CR or PR) till the date of first documented progression or death due to underlying cancer or censoring date (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [22] 0 0
Time to Response (TTR): Part I
Timepoint [22] 0 0
From start date of study drug till first documented response (CR or PR) (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [23] 0 0
TTR: Part II
Timepoint [23] 0 0
From start date of study drug till first documented response (CR or PR) (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [24] 0 0
Disease Control Rate (DCR): Part I
Timepoint [24] 0 0
From start date of study drug till first documented response (CR or PR or SD) (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [25] 0 0
DCR: Part II
Timepoint [25] 0 0
From start date of study drug till first documented response (CR or PR or SD) (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [26] 0 0
Overall Survival (OS): Part II
Timepoint [26] 0 0
From date of start of treatment to date of death due to any cause or censoring date (maximum treatment exposure for Part II was 97.0 weeks)
Secondary outcome [27] 0 0
Summary of Genomic Biomarkers From Tumor Samples: Part I
Timepoint [27] 0 0
Baseline up to end of treatment (EOT) (maximum treatment exposure for Part I was 403.7 weeks)
Secondary outcome [28] 0 0
Plasma Concentration for Encorafenib (LGX): Part I
Timepoint [28] 0 0
C1 (1.5 hrs post-dose on D1; pre-dose, 1.5 hrs post-dose on D15); C2 (pre-dose on D8 and D21); C3 pre-dose on D15; C4 pre-dose on D15; C5 pre-dose on D15; EOT
Secondary outcome [29] 0 0
Plasma Concentration for Encorafenib (LGX): Part II
Timepoint [29] 0 0
C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Secondary outcome [30] 0 0
Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part I
Timepoint [30] 0 0
C1 (1.5 hrs post-dose on D1; pre-dose, 1.5 hrs post-dose on D15); C2 (pre-dose on D8 and D21); C3 pre-dose on D15; C4 pre-dose on D15; C5 pre-dose on D15; EOT
Secondary outcome [31] 0 0
Plasma Concentration for Binimetinib (MEK) and Its Metabolite: Part II
Timepoint [31] 0 0
C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Secondary outcome [32] 0 0
Plasma Concentration for Ribociclib (LEE) and Its Metabolite: Part II
Timepoint [32] 0 0
C1 (1.5, 4 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Secondary outcome [33] 0 0
Plasma Concentration for Infigratinib (BGJ) and Its Metabolites: Part II
Timepoint [33] 0 0
C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6 hrs post-dose on D15; 24 hrs post-dose on D16; pre-dose on D21); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; EOT
Secondary outcome [34] 0 0
Plasma Concentration for Capmatinib (INC): Part II
Timepoint [34] 0 0
C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Secondary outcome [35] 0 0
Plasma Concentration for Buparlisib (BKM): Part II
Timepoint [35] 0 0
C1 (1.5 hrs post-dose on D1; pre-dose on D8; pre-dose, 0.5, 1.5, 2.5, 4, 6, 8 hrs post-dose on D15; 24 hrs post-dose on D16); C2 (pre-dose on D1 and D15); C3 pre-dose on D1; C4 pre-dose on D1; C5 pre-dose on D1; EOT
Secondary outcome [36] 0 0
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Timepoint [36] 0 0
C1 D15: 0.5 hour ± 10 (minutes) min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [37] 0 0
Time to Reach Cmax at Steady State (Tmax, ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Timepoint [37] 0 0
C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [38] 0 0
Area Under the Concentration-time Curve From Time Zero to Time Tau at Steady-State (AUCtau,ss) for Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II
Timepoint [38] 0 0
C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [39] 0 0
Elimination Half-life at Steady State (t1/2, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Capmatinib, and Buparlisib: Part II
Timepoint [39] 0 0
C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [40] 0 0
Apparent Total Plasma Clearance at Steady State (Cl, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II
Timepoint [40] 0 0
C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [41] 0 0
Apparent Volume of Distribution at Steady State (Vz, ss/F) of Encorafenib, Binimetinib, Ribociclib, Capmatinib, and Buparlisib: Part II
Timepoint [41] 0 0
C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [42] 0 0
Last Measurable Plasma Concentration at Steady State (Clast, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Timepoint [42] 0 0
C1 D15: 0.5 hour ± 10 min; 1 hour ± 10 min; 1.5 hour ± 15 min; 2 hour ± 15 min; 2.5 hour ± 15 min; 4 hour ± 30 min; 6 hour ± 30 min; 8 hour ± 60 min; 24 hour ± 2 hour
Secondary outcome [43] 0 0
Measured Concentration at the End of a Dosing Interval at Steady State (Ctrough, ss) of Encorafenib, Binimetinib, Binimetinib Metabolite, Ribociclib, Ribociclib Metabolite, Infigratinib, Infigratinib Metabolites, Capmatinib, and Buparlisib: Part II
Timepoint [43] 0 0
C1 D15: at the end of a dosing interval at steady-state (24 hour ± 2 hour), taken directly before next administration

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

* Age = 18 years
* Histologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IIIC to IV per American Joint Committee on Cancer [AJCC])
* Documented evidence of BRAF V600 mutation.
* Newly obtained tumor biopsy at baseline, and patient agrees to a mandatory biopsy at the time of progression, if not medically contraindicated.
* Evidence of measurable disease, as determined by RECIST v1.1.

INCLUSION CRITERIA for triple combinations:

Progressive disease following prior treatment with LGX818/MEK162 combination. PRINCIPAL EXCLUSION CRITERIA Symptomatic or untreated leptomeningeal disease.

* Symptomatic brain metastases. Patients previously treated or untreated for brain metastases that are asymptomatic in the absence of corticosteroid therapy or on a stable dose of steroids for four weeks are allowed to enroll. Brain metastases must be stable at least 4 weeks with verification by imaging (e.g. brain MRI completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs.
* Patients who have developed brain metastases during Part I of the study may continue to Part II upon discussion with Novartis Medical Monitor. The brain metastasis must be either asymptomatic or treated and stable for at least 4 weeks and on a stable or tapering dose of steroids for at least 2 weeks. Patients with brain metastasis are not eligible for the combination with LEE011.
* Known acute or chronic pancreatitis.
* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes);
* Clinically significant cardiac disease including any of the following:
* CHF requiring treatment (NYH grade = 2),
* LVEF < 50% as determined by MUGA scan or ECHO
* History or presence of clinically significant ventricular arrhythmias or atrial fibrillation
* Clinically significant resting bradycardia
* Unstable angina pectoris = 3 months prior to starting study drug
* Acute Myocardial Infarction (AMI) = 3 months prior to starting study drug,
* QTcF > 480 msec. Patients with any of the following laboratory values at

Screening/baseline:

* Absolute neutrophil count (ANC) <1,500/mm3 [1.5 x 109/L]
* Platelets < 100,000/mm3 [100 x 109/L]
* Hemoglobin < 9.0 g/dL
* Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% LLN (lower limit of normal)
* Serum total bilirubin >1.5 x ULN
* AST/SGOT or ALT/SGPT > 2.5 x ULN, or > 5 x ULN if liver metastases are present

Additional exclusion criteria for the triple combinations:

LGX818/MEK162/BKM120:

* Patients with fasting glucose > 120 mg/dL or 6.7 mmol/L, and HbA1c > 8 %.
* Patient has any of the following mood disorders as judged by the

Investigator or a Psychiatrist:

* Patient has a score = 12 on the PHQ-9 questionnaire
* Patient has = CTCAE grade 3 anxiety

LGX818/MEK162/BGJ398:

* History and/or current evidence of significant ectopic mineralization/ calcification with the exception of calcified lymph nodes and asymptomatic vascular calcification.
* Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivits etc., confirmed by ophthalmologic examination

LGX818/MEK162/LEE011:

* Patients with uncontrolled hypertension (please refer to WHO-ISHguidelines) are excluded from study.
* QTcF >450 ms for males and >470 ms for females Congenital long QT syndrome or family history of unexpected sudden cardiac death and/or hypokalemia CTCAE Grade = 3 and magnesium levels below the clinically relevant lower limits at study entry
* Current evidence of brain metastasis or brain metastasis detected by mandatory CT/MRI at screening
* PT/INR or aPTT > 1.5xULN

Other protocol-defined inclusion/exclusion criteria may apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 2
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
23/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2023
Sample size
Target
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
East St Kilda Eye Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3183 - Melbourne
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
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Germany
State/province [7] 0 0
Baden-württemberg
Country [8] 0 0
Germany
State/province [8] 0 0
Bayern
Country [9] 0 0
Germany
State/province [9] 0 0
Köln
Country [10] 0 0
Germany
State/province [10] 0 0
Muenchen
Country [11] 0 0
Germany
State/province [11] 0 0
Wuerzburg
Country [12] 0 0
Italy
State/province [12] 0 0
Campania
Country [13] 0 0
Italy
State/province [13] 0 0
Napoli
Country [14] 0 0
Netherlands
State/province [14] 0 0
Amsterdam
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zurich Flughafen
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02159066