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MelanomaPhase 1/2NCT01638676

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

A Phase 1/2 study testing Vemurafenib and Metformin in people with Melanoma, run by University of Louisville at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Vemurafenib and Metformin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Jul 2012to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥ 18 years of age;
  • Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
  • Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) 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:
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  • 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.
  • 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 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.

Who cannot join

  • Prior treatment with Vemurafenib;
  • Known hypersensitivity to Metformin or any of its components;
  • Previous progression of melanoma while on Metformin;
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • James Graham Brown Cancer Center-University of Louisville

    Louisville, Kentucky, 40202

    Jason A Chesney, MD PhD, 502-562-3429, jason.chesney@louisville.edu

    Sarah Lush, RN, 502-540-1537, s.lush@louisville.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

This is a Phase I/II study. Phase I will be evaluating the safety of the FDA-approved Vemurafenib (960 mg orally, daily) in combination with Metformin (500 mg orally, twice daily for 2 weeks, then 850 mg orally,twice daily) in patients with unresectable Stage IIIC and Stage IV melanoma. Phase II will evaluate the clinical activity of the combined Vemurafenib/Metformin regimen. The safety profile of this combined Vemurafenib/Metformin regimen will be monitored during both phases. The treatment period consists of 28-day cycles until progression or unacceptable toxicity occurs.

Conditions
Melanoma
Being tested
Vemurafenib, Metformin
Keywords
Unresectable melanoma, Stage IIIC and Stage IV BRAFV600E+ Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VemurafenibDrug

    Also called Vemurafenib branded as Zelboraf

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

  • MetforminDrug

    Also called Metformin hydrochloride branded as Glucophage

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

Study groups in NCT01638676
Study groupRoleWhat they receive
Vemurafenib and MetforminExperimentalNot described
Receives: Drug: Vemurafenib; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observation of CTCAE grade 4 or higher adverse events in six patients

    In the phase I portion, six patients will be enrolled and observed for CTCAE grade 4 or higher events. If three or more grade 4 or higher adverse events are observed among the six patients, the study will be halted.

    Measured: Duration of phase I portion, approximately six months

Secondary outcomes (4)

  1. Overall Survival Follow up

    Patients will be followed for up to three years following the last treatment administration. The Investigator or designees will make every possible attempt at least every 12 weeks (±7 days), for up to three years after the last treatment to contact the patient or family to obtain the survival information of the patient and, if applicable, the start date of additional anticancer treatment.

    Measured: Every 12 weeks (+/- 7 days) after last drug dose, for up to 3 full years

  2. Number of adverse events

    Descriptive statistics of all AEs observed during the study period.

    Measured: Duration of study, estimated to be approximately 60 months

  3. type of adverse events

    Descriptive statistics of all AEs observed during the study period.

    Measured: Duration of study, estimated to be approximately 60 months

  4. Objective response rate (ORR)as measure of efficacy

    Efficacy estimated as the objective response rate (ORR), which is the sum of Partial Responses (PR) and Complete Responses (CR) as determined by RECIST 1.1

    Measured: Duration of study (approximately 60 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01638676
Sponsor's protocol ID
BCC-MEL-11-03
Status last verified
Oct 2021
First submitted
1 Jun 2012
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Cerezo M, Tomic T, Ballotti R, Rocchi S. Is it time to test biguanide metformin in the treatment of melanoma? Pigment Cell Melanoma Res. 2015 Jan;28(1):8-20. doi: 10.1111/pcmr.12267. Epub 2014 Jun 26.

    PubMed 24862830

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vemurafenib and Metformin in people with Melanoma, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01638676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.

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