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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05203172




Registration number
NCT05203172
Ethics application status
Date submitted
10/01/2022
Date registered
24/01/2022

Titles & IDs
Public title
The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
Scientific title
ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
Secondary ID [1] 0 0
FLOTILLA
Secondary ID [2] 0 0
C4221026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Binimetinib only treatment
Treatment: Drugs - Encorafenib only Treatment
Treatment: Drugs - Encorafenib & Binimetinib Treatment
Treatment: Drugs - Treatment of Encorafenib & Binimetinib & Ribociclib
Treatment: Drugs - Treatment of Encorafenib & Binimetinib & Cetuximab

Experimental: Binimetinib only treatment - For those participants receiving binimetinib treatment in parent studies

Experimental: Encorafenib only Treatment - For those participants receiving encorafenib only treatment in parent studies

Experimental: Encorafenib & Binimetinib Treatment - For those participants receiving encorafenib \& binimetinib treatment in parent studies.

Experimental: Treatment of Encorafenib & Binimetinib & Ribociclib - For those participants receiving treatment of encorafenib \& binimetinib \& ribociclib in parent studies

Experimental: Treatment of Encorafenib & Binimetinib & Cetuximab - For those participants receiving treatment of encorafenib \& binimetinib \& cetuximab in parent studies


Treatment: Drugs: Binimetinib only treatment
Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.

Treatment: Drugs: Encorafenib only Treatment
Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.

Treatment: Drugs: Encorafenib & Binimetinib Treatment
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.

Treatment: Drugs: Treatment of Encorafenib & Binimetinib & Ribociclib
Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.

Treatment: Drugs: Treatment of Encorafenib & Binimetinib & Cetuximab
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events leading to permanent discontinuation of study intervention
Timepoint [1] 0 0
Baseline up to approximately 5 years
Primary outcome [2] 0 0
Number serious adverse events reported for all participants
Timepoint [2] 0 0
Baseline up to approximately 5 years

Eligibility
Key inclusion criteria
* Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade =3 or intolerable Grade 2 AEs considered to be related to study treatment.
* Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

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 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
Brazil
State/province [6] 0 0
RIO Grande DO Norte
Country [7] 0 0
Brazil
State/province [7] 0 0
RIO Grande DO SUL
Country [8] 0 0
Brazil
State/province [8] 0 0
SÃO Paulo
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 2
Country [12] 0 0
France
State/province [12] 0 0
Nord
Country [13] 0 0
France
State/province [13] 0 0
Val-de-marne
Country [14] 0 0
Germany
State/province [14] 0 0
Baden-württemberg
Country [15] 0 0
Germany
State/province [15] 0 0
Sachsen-anhalt
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Israel
State/province [18] 0 0
Hatsafon
Country [19] 0 0
Italy
State/province [19] 0 0
Puglia
Country [20] 0 0
Italy
State/province [20] 0 0
Roma
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Italy
State/province [23] 0 0
Napoli
Country [24] 0 0
Japan
State/province [24] 0 0
Nagoya, Aichi
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul-teukbyeolsi [seoul]
Country [26] 0 0
Netherlands
State/province [26] 0 0
Gelderland
Country [27] 0 0
Netherlands
State/province [27] 0 0
Zwolle
Country [28] 0 0
Portugal
State/province [28] 0 0
Lisboa
Country [29] 0 0
Portugal
State/province [29] 0 0
Porto
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Moskva
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Sankt-peterburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moscow
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint Petersburg
Country [34] 0 0
Slovakia
State/province [34] 0 0
Bratislavský KRAJ
Country [35] 0 0
Spain
State/province [35] 0 0
A Coruña [LA Coruña]
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona [barcelona]
Country [37] 0 0
Spain
State/province [37] 0 0
Catalunya [cataluña]
Country [38] 0 0
Spain
State/province [38] 0 0
Lleida [lérida]
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid, Comunidad DE
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Málaga
Country [43] 0 0
Spain
State/province [43] 0 0
Oviedo
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Lancashire
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Preston

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
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
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?

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/NCT05203172