NCT01638676 A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
| NCT ID | NCT01638676 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Louisville |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2012-07 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 55 participants in total. It began in 2012-07 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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
Contact & Investigator
Jason A Chesney, MD PhD
PRINCIPAL INVESTIGATOR
James Graham Brown Cancer Center-U of Louisville
Frequently Asked Questions
Who can join the NCT01638676 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01638676 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01638676 currently recruiting?
Yes, NCT01638676 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Louisville to inquire about joining.
Where is the NCT01638676 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT01638676 clinical trial?
NCT01638676 is sponsored by University of Louisville. The principal investigator is Jason A Chesney, MD PhD at James Graham Brown Cancer Center-U of Louisville. The trial plans to enroll 55 participants.
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