Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients
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ClinicalTrials.gov Identifier: NCT02143050 |
Recruitment Status :
Recruiting
First Posted : May 20, 2014
Last Update Posted : October 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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Melanoma | Drug: Dabrafenib Drug: Trametinib Drug: Metformin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 53 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Trial of Dabrafenib, Trametinib and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF V600E + Melanoma Patients |
Study Start Date : | September 2014 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Dabrafenib, Trametinib and Metformin
Dabrafenib 150 mg PO BID until progression or unacceptable toxicity. Trametinib 2 mg PO QD until progression or unacceptable toxicity. Metformin 500 mg PO BID x 2 weeks, then 850 mg PO BID until progression or unacceptable toxicity.
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Drug: Dabrafenib
Other Name: Tafinlar Drug: Trametinib Other Name: Mekinist Drug: Metformin Other Name: Glucophage |
- Observation of two CTCAE drug related grade 4 toxicities in six patients. [ Time Frame: Duration of phase I portion, approxiately 6 months ]During phase I, six patients will be enrolled and monitored for toxicities. If drug related deaths occur or more than two drug related CTCAE grade 4 toxicities occur the trial will be suspended. Phase II will estimate the efficacy of the drugs, enrolling 20 patients during stage 1 with an upper limit of 39 for the 2nd stage.
- Clinical Response Rate [ Time Frame: 6 years ]Phase II will study the efficacy of the drugs enrolling 20 patients during stage I with an upper limit of 39 for the 2nd stage.
- To estimate the overall survival rates. [ Time Frame: Approximately 3 years ]Patients will be contacted every 3 months following treatment administration for up to three years to obtain survival data.
- To explore the effect of other covariates on overall survival [ Time Frame: 3 years ]To identify demographic, disease and treatment related effects on overall survival.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients > 18 years of age
- Patients with histologically confirmed BRAFV600E melanoma (Stage IIIC or
- Stage IV, American Joint Commission on Cancer)
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Life expectancy > 3 months
- At least 1 site of radiographically measurable disease by RECIST 1.1
- Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
- Absolute neutrophil count > 1.0 x 10⁹/L
- Platelet count > 50 x 10⁹/L
- Hemoglobin > 8 g/dL
- Serum creatinine < 2 x upper limit of normal
- Total serum bilirubin < 3 x ULN
- Serum aspartate transaminase or serum alanine transaminase < 3 x ULN, and < 4 x ULN if liver metastases are present
- 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
- 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 the study drug
- Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for > 1 year
- Before study entry, written informed consent must be obtained from the patient prior to performing any study related procedures
Exclusion Criteria:
- Prior treatment with Vemurafenib or Dabrafenib
- Known hypersensitivity to Metformin or any of its components
- 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
- Pregnant, breast feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures
- Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143050
Contact: Stacy Baum, BSN | 502-562-2280 | msbaum02@louisville.edu | |
Contact: Karen Carter, BSN | 502-562-3690 | kmcart05@louisville.edu |
United States, Kentucky | |
James Graham Brown Cancer Center-Universityof Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Jason A Chesney, MD, PhD 502-562-3429 jason.chesney@louisville.edu | |
Contact: Christina LaDuke 502-217-5205 christy.laduke@louisville.edu | |
Sub-Investigator: Donald M Miller, MD, PhD | |
Sub-Investigator: Kelly M McMasters, MD, PhD | |
Sub-Investigator: Sucheta Telang, MD | |
James Graham Brown Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Karen Carter, BSN 502-562-3690 kmcart05@louisville.edu | |
Contact: Christina LaDuke, BS 502-217-5205 christi.laduke@louisville.edu |
Principal Investigator: | Jason A Chesney, MD, PhD | James Graham Brown Cancer Center |
Responsible Party: | Jason Chesney, Director, James Graham Brown Cancer Center, University of Louisville |
ClinicalTrials.gov Identifier: | NCT02143050 |
Other Study ID Numbers: |
BCC-MEL-14-01 |
First Posted: | May 20, 2014 Key Record Dates |
Last Update Posted: | October 29, 2021 |
Last Verified: | October 2021 |
Unresectable melanoma Stage IIIC and Stage IV BRAF V600E+ |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Metformin |
Trametinib Dabrafenib Hypoglycemic Agents Physiological Effects of Drugs Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |