RECRUITING

A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients

Conditions

Melanoma Unresectable melanoma Stage IIIC and Stage IV BRAFV600E+ Melanoma

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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 main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

Official Title

A Phase I/II Trial of Vemurafenib and Metformin to Unresectable Stage IIIC and Stage IV BRAF.V600E+ Melanoma Patients

Quick Facts

Study Start:2012-07

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01638676

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 Criteria	Exclusion Criteria
1. Male or female patients ≥ 18 years of age; 2. Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer); 3. Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 2; 4. Life expectancy ≥ 3 months; 5. At least 1 site of radiographically measurable disease by RECIST 1.1 6. Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing: * Absolute neutrophil count (ANC) ≥ 1.0 x 109/L; * Platelet count ≥ 50 x 109/L; * Hemoglobin ≥ 8 g/dL; * Serum creatinine ≤ 2 x upper limit of normal (ULN) * Total serum bilirubin ≤ 3 x ULN; * Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present. 7. Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician; 8. Pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year; 9. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.	1. Prior treatment with Vemurafenib; 2. Known hypersensitivity to Metformin or any of its components; 3. Previous progression of melanoma while on Metformin; 4. Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia; 5. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures; 6. Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study

Inclusion Criteria

Exclusion Criteria

1. Male or female patients ≥ 18 years of age;
2. Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
3. Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 2;
4. Life expectancy ≥ 3 months;
5. At least 1 site of radiographically measurable disease by RECIST 1.1
6. Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
* Absolute neutrophil count (ANC) ≥ 1.0 x 109/L;
* Platelet count ≥ 50 x 109/L;
* Hemoglobin ≥ 8 g/dL;
* Serum creatinine ≤ 2 x upper limit of normal (ULN)
* Total serum bilirubin ≤ 3 x ULN;
* Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present.
7. Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
8. Pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year;
9. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

1. Prior treatment with Vemurafenib;
2. Known hypersensitivity to Metformin or any of its components;
3. Previous progression of melanoma while on Metformin;
4. Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia;
5. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
6. Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study

Contacts and Locations

Principal Investigator

Jason A Chesney, MD PhD

PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center-U of Louisville

Study Locations (Sites)

James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: University of Louisville

Jason A Chesney, MD PhD, PRINCIPAL_INVESTIGATOR, James Graham Brown Cancer Center-U of Louisville

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 Date2012-07

Study Completion Date2027-06

Study Record Updates

Study Start Date2012-07

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Unresectable melanoma
Stage IIIC and Stage IV BRAFV600E+ Melanoma

Additional Relevant MeSH Terms

Melanoma