Clinical trial · Interventional
Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients
A Phase I/II Trial of Dabrafenib, Trametinib and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF V600E + Melanoma Patients
NCT02143050CI-TRIAL-00071448withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participant enrollment
Summary
Brief summary (as posted)
The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Metformin | Drug | Metformin | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dabrafenib, Trametinib and Metformin
- description
- 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.
- interventionNames
- Drug: Dabrafenib
- Drug: Trametinib
- Drug: Metformin
Primary outcomes (2)
- measure
- Observation of two CTCAE drug related grade 4 toxicities in six patients.
- timeFrame
- Duration of phase I portion, approxiately 6 months
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.