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BRAF Inhibitor

Phenformin + BRAF/MEK Inhibitors for Melanoma

Phase 1

Waitlist Available

Led By Michael Postow, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether giving phenformin with a standard drug combination for treating melanoma is safe.

Who is the study for?

This trial is for adults with advanced melanoma that has a specific BRAF V600 mutation. Participants must be in good physical condition, have measurable cancer growth, and their major organs need to function well. They can't join if they're pregnant, on certain medications like other BRAF inhibitors or steroids beyond replacement doses, have diabetes or severe lung disease, or any other serious health issues.Check my eligibility

What is being tested?

The study tests the safety of combining Phenformin with standard FDA-approved treatments (Trametinib and Dabrafenib) for metastatic melanoma with a BRAF mutation. It aims to see how well patients tolerate this combination and what effects it has on their cancer.See study design

What are the potential side effects?

Potential side effects may include digestive problems, blood sugar changes due to Phenformin; skin rash, fever from Dabrafenib; and vision changes or heart issues from Trametinib. Each drug also carries its own risk profile which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Disease-free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dabrafenib, Trametinib & PhenforminExperimental Treatment3 Interventions

This is a multi-institution single-arm phase I trial with an expansion cohort at the MTD of Phenformin, in patients with metastatic BRAFV600E/K mutated melanoma. In the dose escalation phase, cohorts of patients will be treated with standard dose Dabrafenib (150 mg PO BID) plus Trametinib (2 mg PO QD) and increasing doses of Phenformin. In the dose-escalation phase of the trial, both patients who have already been treated with a BRAF and/or MEK inhibitor, and treatment-naïve patients will be eligible. The maximally tolerated Phenformin dose was determined to be 100 mg BID. The dose-expansion cohort will enroll up to 10 patients who are treatment- naïve for BRAF inhibitor. In this cohort, patients may be treated with any of the 3 FDA-approved BRAFi/MEKi combinations: dabrafenib/trametinib, vemurafenib/cobimetinib, or encorafenib/binimetinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1550

Dabrafenib

2011

Completed Phase 3

~4120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER

1,055 Previous Clinical Trials

1,316,280 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,937 Previous Clinical Trials

588,302 Total Patients Enrolled

76 Trials studying Melanoma

15,960 Patients Enrolled for Melanoma

Massachusetts General HospitalOTHER

2,937 Previous Clinical Trials

13,199,032 Total Patients Enrolled

22 Trials studying Melanoma

1,081 Patients Enrolled for Melanoma

Media Library

Melanoma Research Study Groups: Dabrafenib, Trametinib & Phenformin

Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT03026517 — Phase 1

Frequently Asked Questions

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

Has Phenformin been granted the greenlight by the FDA?

"Phenformin has been assigned a safety score of 1, due to the limited clinical data supporting its efficacy and no prior evidence concerning its safety."

Answered by AI

Have any other scientific investigations explored the effects of Phenformin?

"Currently, there are 95 active studies involving Phenformin. 6 of those research endeavors have reached Phase 3 status and they can be found in Honolulu, Hawaii; but if one were to expand their search parameters, then a total of 5805 trial sites become available."

Answered by AI

Is this research project presently recruiting participants?

"The trial is not accepting candidates currently, having been initially posted on January 1st 2017 and edited as recently as June 14th 2022. If you are still interested in participating in a medical study, 753 clinical trials for melanoma and 95 studies related to Phenformin are actively enrolling patients."

Answered by AI

How many people have enrolled in this medical trial thus far?

"At present, this research trial is not accepting new participants. It was initially posted in January 2017 and updated as recently as June 2022. For those seeking alternative medical studies, 753 are actively recruiting for melanoma patients while 95 opportunities exist for Phenformin trials."

Answered by AI

Recent research and studies

mycnJournal

Catastrophic ATP Loss Underlies a Metabolic Combination Therapy Tailored for <i>mycn</i> -amplified Neuroblastoma

Dalton, Krista M., Timothy L. Lochmann, Konstantinos V. Floros, Marissa L. Calbert, Richard Kurupi, Giovanna T. Stein, Joseph McClanaghan, et al.. 2021. “Catastrophic ATP Loss Underlies a Metabolic Combination Therapy Tailored for mycn -amplified Neuroblastoma”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.2009620118.

clinicaltrials.govStudy

Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma

2017. "Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03026517.

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