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| ID | Type | Description | Link |
|---|---|---|---|
| FLOTILLA | Other Identifier | Alias Study Number | |
| 2023-509408-13-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib.
All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib.
Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.
This is an open-label, continuation study for participants receiving study intervention(s) in an encorafenib/binimetinib Parent Study. The study is being conducted under a Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies with an individual encorafenib/binimetinib continuation sub-study protocol for each eligible Parent Study. Approximately 75 participants from potentially qualifying Parent Studies will be included in this Encorafenib/Binimetinib Continuation study.
This continuation study includes multiple sub-study protocols to allow participants from each of the following parent studies: C4211001 - NCT01320085; C4211003 - NCT01849874; C4221003 - NCT03864042; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binimetinib only treatment | Experimental | For those participants receiving binimetinib treatment in parent studies |
|
| Encorafenib only Treatment | Experimental | For those participants receiving encorafenib only treatment in parent studies |
|
| Encorafenib & Binimetinib Treatment | Experimental | For those participants receiving encorafenib & binimetinib treatment in parent studies. |
|
| Treatment of Encorafenib & Binimetinib & Ribociclib | Experimental | For those participants receiving treatment of encorafenib & binimetinib & ribociclib in parent studies |
|
| Treatment of Encorafenib & Binimetinib & Cetuximab | Experimental | For those participants receiving treatment of encorafenib & binimetinib & cetuximab in parent studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binimetinib only treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events leading to permanent discontinuation of study intervention | Baseline up to approximately 5 years | |
| Number serious adverse events reported for all participants | Baseline up to approximately 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Recruiting | Phoenix | Arizona | 85004 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Each participant will continue to receive the same study treatment regimen at the same dose level as that received in the Parent Studies.
The details of study intervention and duration of treatment are specified in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
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| Encorafenib only Treatment | Drug | Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study. |
|
| Encorafenib & Binimetinib Treatment | Drug | 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 of Encorafenib & Binimetinib & Ribociclib | Drug | 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 of Encorafenib & Binimetinib & Cetuximab | Drug | 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. |
|
| St. Joseph's Hospital and Medical Center |
| Recruiting |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| Investigational Drug Service Emory University Clinic | Recruiting | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute of Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| HealthPartners Cancer Research Center | Recruiting | Saint Paul | Minnesota | 55101 | United States |
| Regions Hospital Pharmacy | Recruiting | Saint Paul | Minnesota | 55101 | United States |
| Siteman Cancer Center | Recruiting | St Louis | Missouri | 63108 | United States |
| Barnes-Jewish Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| MSK Basking Ridge | Active, not recruiting | Basking Ridge | New Jersey | 07920 | United States |
| Rockefeller Outpatient Pavilion (53rd Street) | Active, not recruiting | New York | New York | 10022 | United States |
| Memorial Sloan Kettering Cancer Center | Active, not recruiting | New York | New York | 10065 | United States |
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | United States |
| Investigational Chemotherapy Service | Recruiting | Durham | North Carolina | 27710 | United States |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Liga Norte Riograndense Contra o Câncer | Recruiting | Natal | Rio Grande do Norte | 59062-000 | Brazil |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia | Recruiting | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Fundação Pio XII - Hospital de Câncer de Barretos | Recruiting | Barretos | São Paulo | 14.780-070 | Brazil |
| BP - A Beneficencia Portuguesa de São Paulo | Recruiting | São Paulo | São Paulo | 01321-001 | Brazil |
| Real e Benemerita Associacao Portuguesa de Beneficencia | Recruiting | São Paulo | São Paulo | 01323-030 | Brazil |
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | Praha 2 | 12808 | Czechia |
| Hopital Claude Huriez - CHU de Lille | Active, not recruiting | Lille | NORD | 59037 | France |
| Gustave Roussy | Active, not recruiting | Villejuif | Val-de-marne | 94800 | France |
| Universitaetsklinikum Tuebingen | Active, not recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Otto-von-Guericke-Universitat Magdeburg | Active, not recruiting | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Charité Universitaetsmedizin Berlin - Campus Mitte | Recruiting | Berlin | 10117 | Germany |
| Debreceni Egyetem Klinikai Kozpont | Recruiting | Debrecen | 4032 | Hungary |
| Rambam Health Care Campus | Recruiting | Haifa | Northern District | 3109601 | Israel |
| Instituto Tumori Giovanni Paolo II | Recruiting | Bari | Apulia | 70124 | Italy |
| Istituto Nazionale Tumori Regina Elena | Recruiting | Rome | ROMA | 00144 | Italy |
| Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia | Recruiting | Candiolo | Torino | 10060 | Italy |
| Istituto Oncologico Veneto IRCCS | Recruiting | Padova | Veneto | 35128 | Italy |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Recruiting | Bologna | 40138 | Italy |
| Istituto Europeo di Oncologia IRCCS | Active, not recruiting | Milan | 20141 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale | Recruiting | Naples | 80131 | Italy |
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
| Isala, locatie Zwolle | Active, not recruiting | Zwolle | 8025 AB | Netherlands |
| Instituto Português de Oncologia de Lisboa Francisco Gentil | Recruiting | Lisbon | Lisbon District | 1099-023 | Portugal |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Recruiting | Porto | 4200-072 | Portugal |
| N.N.Petrov Research Institute of Oncology | Recruiting | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF | Recruiting | Moscow | 115478 | Russia |
| N.N.Petrov Research Institute of Oncology | Recruiting | Saint Petersburg | 197758 | Russia |
| Narodny onkologicky ustav | Active, not recruiting | Bratislava | Bratislava Region | 833 10 | Slovakia |
| Seoul National University Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 06351 | South Korea |
| CHUAC-Hospital Teresa Herrera | Recruiting | A Coruña | A Coruña [LA Coruña] | 15006 | Spain |
| Institut Català d'Oncologia (ICO) - Badalona | Recruiting | Badalona | Barcelona [barcelona] | 08916 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona [barcelona] | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | Catalunya [cataluña] | 08008 | Spain |
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Catalunya [cataluña] | 08036 | Spain |
| Hospital Universitario Arnau de Vilanova de Lleida | Recruiting | Lleida | Lleida [lérida] | 25198 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Majadahonda | Madrid, Comunidad de | 28222 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | 29010 | Spain |
| H.R.U Málaga - Hospital General | Recruiting | Málaga | 29011 | Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
| Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital | Recruiting | Preston | Lancashire | PR2 9HT | United Kingdom |
| ID | Term |
|---|---|
| C000601108 | encorafenib |
| C581313 | binimetinib |
| C000589651 | ribociclib |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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