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Kinase Inhibitor

Encorafenib + Binimetinib Access for Cancer

Q: Has the FDA sanctioned utilization of Encorafenib & Binimetinib Treatment?

<p>At Power, we have rated the safety of Encorafenib &#x26; Binimetinib Treatment as a 3 out of 3 due to its Phase 4 status, which implies that it has already been approved.</p>

Phase 4

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant receiving study intervention and deriving clinical benefit in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs related to study treatment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 5 years

Awards & highlights

Study Summary

This trial is for people who were in a prior study for encorafenib and/or binimetinib and are still benefiting from the use of the study medicines. People in the trial will receive the same dose and frequency of encorafenib and/or binimetinib as they did in the prior study, for up to about 5 years.

Who is the study for?

The FLOTILLA study is for people with solid tumors who have previously benefited from encorafenib and/or binimetinib in earlier trials. They must be seeing ongoing benefits without severe side effects, as judged by their doctor, and agree to follow specific reproductive guidelines.Check my eligibility

What is being tested?

This trial provides continued access to encorafenib and binimetinib, alone or combined with ribociclib or cetuximab, for those previously treated with these drugs. The aim is safety monitoring while allowing participants to keep taking the same doses for up to five years.See study design

What are the potential side effects?

While not specified here, common side effects of cancer treatments like encorafenib and binimetinib can include fatigue, skin reactions, nausea, diarrhea, liver issues and increased risk of bleeding. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am benefiting from an encorafenib/binimetinib study without severe side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events leading to permanent discontinuation of study intervention

Number serious adverse events reported for all participants

Trial Design

5Treatment groups

Experimental Treatment

Group I: Treatment of Encorafenib & Binimetinib & RibociclibExperimental Treatment1 Intervention

For those participants receiving treatment of encorafenib & binimetinib & ribociclib in parent studies

Group II: Treatment of Encorafenib & Binimetinib & CetuximabExperimental Treatment1 Intervention

For those participants receiving treatment of encorafenib & binimetinib & cetuximab in parent studies

Group III: Encorafenib only TreatmentExperimental Treatment1 Intervention

For those participants receiving encorafenib only treatment in parent studies

Group IV: Encorafenib & Binimetinib TreatmentExperimental Treatment1 Intervention

For those participants receiving encorafenib & binimetinib treatment in parent studies.

Group V: Binimetinib only treatmentExperimental Treatment1 Intervention

For those participants receiving binimetinib treatment in parent studies

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,910,432 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,091,546 Total Patients Enrolled

Media Library

Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05203172 — Phase 4

Solid Tumors Research Study Groups: Encorafenib & Binimetinib Treatment, Treatment of Encorafenib & Binimetinib & Ribociclib, Binimetinib only treatment, Treatment of Encorafenib & Binimetinib & Cetuximab, Encorafenib only Treatment

Solid Tumors Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT05203172 — Phase 4

Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05203172 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still slots open for enrolment in this experiment?

"Affirmative. According to clinicaltrials.gov, 46 participants are being sought for this ongoing trial which was first published on July 5th 2022 and last updated November 17th of the same year. It is recruiting at five different medical facilities."

Answered by AI

What is the size of the participant pool for this research trial?

"Affirmative, the available information from clinicaltrials.gov suggests that this health-based study is seeking volunteers at present. This experiment was first publicized on July 5th 2022 and most recently updated on November 17th 2022. The research requires 46 participants across five clinic locations."

Answered by AI

In what areas is this research trial being conducted?

"Currently, the trial is being conducted in St. Joseph's Hospital and Medical Centre located in Phoenix, Arizona; Memorial Sloan Kettering Cancer Center situated in New york City; MSK Basking Ridge based in Basking Ridge, New jersey as well as a further 5 locations."

Answered by AI

Has the FDA sanctioned utilization of Encorafenib & Binimetinib Treatment?

"At Power, we have rated the safety of Encorafenib & Binimetinib Treatment as a 3 out of 3 due to its Phase 4 status, which implies that it has already been approved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05203172.