Continued access to encorafenib and binimetinib for previous trial participants
ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
PHASE4 · Pfizer · NCT05203172
This study is for people who have previously taken the medications encorafenib and binimetinib and want to continue using them safely for up to five years if they are still benefiting from the treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Drugs / interventions | binimetinib |
| Locations | 67 sites (Phoenix, Arizona and 66 other locations) |
| Trial ID | NCT05203172 on ClinicalTrials.gov |
What this trial studies
The FLOTILLA study aims to provide ongoing access to the medications encorafenib and binimetinib for participants who have previously benefited from these treatments in earlier clinical trials. This open-label continuation study allows eligible participants to receive the same dosage and frequency of the medications for up to five years, ensuring safety follow-up and monitoring. Participants must have been part of prior studies involving these drugs and must still be experiencing clinical benefits as determined by their study doctor.
Who should consider this trial
Good fit: Ideal candidates are individuals who have participated in prior clinical trials of encorafenib and/or binimetinib and are still deriving clinical benefit from these treatments.
Not a fit: Patients who have not previously enrolled in a study involving encorafenib or binimetinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide continued treatment options for patients with solid tumors who have previously responded well to encorafenib and binimetinib.
How similar studies have performed: Other studies involving encorafenib and binimetinib have shown promise, indicating that this continuation approach may build on previously established benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: * Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Where this trial is running
Phoenix, Arizona and 66 other locations
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (RECRUITING)
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (RECRUITING)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- Investigational Drug Service Emory University Clinic — Atlanta, Georgia, United States (RECRUITING)
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- HealthPartners Cancer Research Center — Saint Paul, Minnesota, United States (RECRUITING)
- Regions Hospital Pharmacy — Saint Paul, Minnesota, United States (RECRUITING)
- Siteman Cancer Center — St Louis, Missouri, United States (RECRUITING)
- Barnes-Jewish Hospital — St Louis, Missouri, United States (RECRUITING)
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
- Washington University — St Louis, Missouri, United States (RECRUITING)
- MSK Basking Ridge — Basking Ridge, New Jersey, United States (ACTIVE_NOT_RECRUITING)
- Rockefeller Outpatient Pavilion (53rd Street) — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- Duke Cancer Center — Durham, North Carolina, United States (RECRUITING)
- Investigational Chemotherapy Service — Durham, North Carolina, United States (RECRUITING)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (RECRUITING)
- Liga Norte Riograndense Contra o Câncer — Natal, Rio Grande do Norte, Brazil (RECRUITING)
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia — Ijuí, Rio Grande do Sul, Brazil (RECRUITING)
- Fundação Pio XII - Hospital de Câncer de Barretos — Barretos, São Paulo, Brazil (RECRUITING)
- BP - A Beneficencia Portuguesa de São Paulo — São Paulo, São Paulo, Brazil (RECRUITING)
- Real e Benemerita Associacao Portuguesa de Beneficencia — São Paulo, São Paulo, Brazil (RECRUITING)
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
- Jewish General Hospital — Montreal, Quebec, Canada (RECRUITING)
- Vseobecna fakultni nemocnice v Praze — Prague, Praha 2, Czechia (RECRUITING)
- Hopital Claude Huriez - CHU de Lille — Lille, NORD, France (ACTIVE_NOT_RECRUITING)
- Gustave Roussy — Villejuif, Val-de-marne, France (ACTIVE_NOT_RECRUITING)
- Universitaetsklinikum Tuebingen — Tübingen, Baden-Wurttemberg, Germany (ACTIVE_NOT_RECRUITING)
- Otto-von-Guericke-Universitat Magdeburg — Magdeburg, Saxony-Anhalt, Germany (ACTIVE_NOT_RECRUITING)
- Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin, Germany (RECRUITING)
- Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary (RECRUITING)
- Rambam Health Care Campus — Haifa, Northern District, Israel (RECRUITING)
- Instituto Tumori Giovanni Paolo II — Bari, Apulia, Italy (RECRUITING)
- Istituto Nazionale Tumori Regina Elena — Rome, ROMA, Italy (RECRUITING)
- Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo, Torino, Italy (RECRUITING)
- Istituto Oncologico Veneto IRCCS — Padova, Veneto, Italy (RECRUITING)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna, Italy (RECRUITING)
- Istituto Europeo di Oncologia IRCCS — Milan, Italy (ACTIVE_NOT_RECRUITING)
- Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples, Italy (RECRUITING)
- Radboudumc — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) — Amsterdam, North Holland, Netherlands (RECRUITING)
- Isala, locatie Zwolle — Zwolle, Netherlands (ACTIVE_NOT_RECRUITING)
- Instituto Português de Oncologia de Lisboa Francisco Gentil — Lisbon, Lisbon District, Portugal (RECRUITING)
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE — Porto, Portugal (RECRUITING)
- N.N.Petrov Research Institute of Oncology — Saint Petersburg, Sankt-Peterburg, Russia (RECRUITING)
- Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF — Moscow, Russia (RECRUITING)
- N.N.Petrov Research Institute of Oncology — Saint Petersburg, Russia (RECRUITING)
+17 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumors