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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2011-001793-26-GB
Date of registration: 13/09/2011
Prospective Registration: Yes
Primary sponsor: Royal Marsden Hospital
Public title: A Phase II Trial of Metformin and Axitinib in BRAF Mutated Advanced Melanoma (MAXIM)
Scientific title: A Phase II Trial of Metformin and Axitinib in BRAF Mutated Advanced Melanoma - MAXIM
Date of first enrolment: 31/10/2011
Target sample size: 48
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001793-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Amy Thomas   
Address:  Fulham Road SW3 6JJ London United Kingdom
Telephone: 02078082710
Email: amy.thomas@rmh.nhs.uk
Affiliation:  The Royal Marsden Hospital
Name: Amy Thomas   
Address:  Fulham Road SW3 6JJ London United Kingdom
Telephone: 02078082710
Email: amy.thomas@rmh.nhs.uk
Affiliation:  The Royal Marsden Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
1.Advanced melanoma defined as unresectable locally advanced or metastatic disease 2.The presence of one or more clinically or radiologically measurable lesions at least 10mm in size 3.Age 18 or greater 4.ECOG performance status 0 or 1 5.Life expectancy greater than 12 weeks 6.At least 28 days since any major surgery 7.The capacity to understand the patient information sheet and ability to provide written informed consent 8.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures 9.Women must not be pregnant or lactating with no intention of pregnancy during study treatment. Women of child bearing potential must have a negative serum pregnancy test prior to study entry (even if surgically sterilised). Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 6 months after receiving the last study treatment 10.Serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), total serum bilirubin =1.5 x ULN 11.Serum creatinine =1.5 x ULN 12.Serum lipase and amylase <1.5 x ULN 13.Haemoglobin =9.0 g/dL, absolute neutrophil count =1.5 x 109/L, platelets =100 x 109/L 14.Prothrombin time (PT) =1.5 x ULN 15.Able to swallow and retain oral medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion criteria:
1.Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days 2.Women who are pregnant, nursing, or planning to become pregnant during the course of the trial 3.Men who plan to father a child during the course of the trial 4.Use of any investigational drug within 30 days prior to screening (both cancer and non cancer treatments) 5.Use of herbal or chinese medication 6.Use of therapeutic coumarin derivatives (ie warfarin, acenoucumarol, phenprocoumon) 7.Significant cardiac disease 8.Severe and/or uncontrolled medical disease 9.Known chronic liver disease 10.Known HIV infection 11.Previous radiotherapy to 25% or more of the bone marrow 12.Radiation therapy in the 4 weeks prior to study entry 13.Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn’s disease or ulcerative colitis).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Advanced BRAF mutant melanoma
Therapeutic area: Diseases [C] - Cancer [C04]
Intervention(s)

Product Name: Axitinib
Product Code: (AG-013736)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Axitinib
CAS Number: 319460-85-0
Current Sponsor code: AG-013736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: Axitinib
CAS Number: 319460-85-0
Current Sponsor code: AG-013736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Metformin
Product Name: Metformin
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: Metformin Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-

Primary Outcome(s)
Main Objective: Is the combination of axitinib and metformin efficacious in BRAF mutant advanced melanoma?
Primary end point(s): Efficacy of the combination of axitinib and metformin
Secondary Objective: What is the toxicity of the combination? What molecular changes result in tumours as a consequence?
Timepoint(s) of evaluation of this end point: Proportion of patients who have progression free survival after 6 months.Progression free survival times will be measured from the date of enrolment into the treatment phase until the first date (following start of treatment) of either death or confirmed progressive disease according to RECIST.
Secondary Outcome(s)
Secondary end point(s): 1.Response rate at 12 weeks 2.Overall survival 3.Toxicity of treatment 4.Correlation between molecular changes and response to treatment and survival
Timepoint(s) of evaluation of this end point: There will be too few instances of progression/death in 24 patients in each cohort to be able to make confident statements about the relationship of outcome to these factors using PFS at 6 months as an endpoint. The effect sizes from such analyses will therefore only be presented together with their 95% confidence intervals as a guide to the ranges within which these effects might lie.
Secondary ID(s)
3590
Source(s) of Monetary Support
Pfizer
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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