RECRUITING

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES

Quick Facts

Study Start:2022-07-05
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05203172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
  1. * Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85004
United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101
United States
Regions Hospital Pharmacy
Saint Paul, Minnesota, 55101
United States
HealthPartners Specialty Center
Saint Paul, Minnesota, 55130
United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Rockefeller Outpatient Pavilion (53rd Street)
New York, New York, 10022
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-05
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-07-05
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors