Patients with histologically confirmed metastatic melanoma
Conditions
Interventions
Trade Name: Zelboraf
Product Name: Zelboraf
Pharmaceutical Form: Film-coated tablet
Pharmaceutical Form: Capsule, hard
Sponsors
Finnish melanoma group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Signed informed consent obtained prior to any study specific screening procedures 2. Histologically confirmed inoperable stage III or stage IV metastatic melanoma 3. Performance status: WHO 0-2 4. Measurable or evaluable disease according to RECIST 1.1 5. BRAF mutation status should be analysed; if technically not possible the patient is treated as BRAF negative 6. Age ?18 years of age 7. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study 8. Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment 9. Previous adjuvant therapy is allowed 10. Previous immunotherapy in the metastatic setting is allowed 11. Patients with previously treated, asymptomatic brain metastases are allowed 12. Neutrophils ? 1’200/?l, Platelets ? 100’000/?l, Alanine amino transferase ? 2.5 ? Upper limit of normal (ULN) (=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Prior systemic treatment for metastatic melanoma (except for immunotherapy) 2. Symptomatic brain metastases not responding to corticosteroids and radiotherapy 3. Presence of active gastrointestinal disease or condition that will interfere significantly with the intake of drugs 4. Presence of malignancy other than cutaneous metastatic melanoma (Stage IV) within 5 years of study enrollment except for curatively treated basal and squamous cell carcinoma of the skin or In-situ carcinoma of the cervix 5. Corrected QT (QTc) interval ?500 ms. 6. Uncontrolled medical conditions (i.e, diabetes mellitus, heart disorders, hypertension, etc), psychological, social, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol 7. Pregnant or lactating females 8. Non-evaluable disease 9. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk for treatment complications 10. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 11. Previous chemotherapy for metastatic melanoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate response rate according to the RECIST v.1.1 criteria. Response rate will be evaluated separately for each treatment arm.;Secondary Objective: To evalute progression-free survival, Toxicity and safety of treatment, Overall survival, Progression-free survival at 6 months, Time to brain metastases or their progression, QOL (15-D questionnaire);Primary end point(s): Response Rate according to RECIST 1.1 criteria. Response rate will be evaluated separately for each treatment arm. ;Timepoint(s) of evaluation of this end point: response rate: RECIST 1.1 (time frame: 2 year) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression Free Survival (overall and at 6 months) (both progression after chemotherapy (PDct) and PD) • Overall Survival (defined as the time period from the start of therapy to death) • Time to brain metastases or their progression • QOL (15-D questionnaire) - Safety assessment will consist of evaluating laboratory parameters and recording adverse events according to NCI CTCAE v 4.0;Timepoint(s) of evaluation of this end point: - Safety: Incidence of adverse events (time frame: 2 year) | — |
Countries
Finland
Contacts
Public ContactFinnish melanoma group
Micaela Hernberg
Outcome results
None listed