Recruiting
Phase 1
Phase 2

Vemurafenib & Metformin

Sponsor:

University of Louisville

Code:

NCT01638676

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vemurafenib

Metformin

Study Details

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.

Conditions

Melanoma

Study ID

NCT01638676

Start date

Jul, 2012

Status verified date

Oct, 2021

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vemurafenib and Metformin

Interventions

Vemurafenib

Vemurafenib (960 mg PO daily) in patients with unresectable BRAFV600E positive Stage IIIC and Stage IV melanoma

Metformin

Metformin (500 mg PO BID x 2 weeks, then 850 mg PO BID)

Primary outcome measure

  • Observation of CTCAE grade 4 or higher adverse events in six patients [ Time Frame: Duration of phase I portion, approximately six months ]

Central Contacts and Locations

Locations

James Graham Brown Cancer Center-University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

More Information

Sponsor

University of Louisville

Last update posted

Oct 29, 2021

Last verified

Oct, 2021

Keywords

  • Unresectable melanoma
  • Stage IIIC and Stage IV BRAFV600E+ Melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2021-10-29.