Unresectable AJCC Stage 3 or 4 Malignant Melanoma
Conditions
Interventions
Product Name: AZD6244
Product Code: AZD6244
Pharmaceutical Form: Powder for oral suspension
CAS Number: 606143-52-6
Other descriptive na
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Female or male aged 18 years and over 3. Histological or cytological confirmation of unresectable AJCC stage 3 or 4 malignant melanoma 4. At least one measurable site of disease (using imaging techniques) as defined by RECIST 5. WHO performance status 0-2 (patients performance status 2 must have been stable with no deterioration over the previous 2 weeks) 6. Willing to provide a fresh, or archival tumour biopsy for determination of BRAF and NRAS mutational status 7. Evidence of post-menopausal status, or negative urinary pregnancy test for female pre-menopausal patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Laboratory values as listed below: - Absolute Neutrophil Count (ANC) 450 ms 13. Presence of factors that may increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalaemia, family history, or long QT syndrome) 14. Receiving concomitant medication that may cause QT prolongation 15. Known hypersensitivity to AZD6244, Captisol®, or temozolomide 16. Female patients who are breast feeding, or patients of reproductive potential not employing an effective method of birth control 17. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) 18. Previous enrolment or randomisation of treatment in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma; Secondary Objective: To assess the safety and tolerability of AZD6244 in patients with unresectable AJCC stage 3 or 4 malignant melanoma To investigate the pharmacokinetics of AZD6244 and N-desmethyl AZD6244 following BD dosing To investigate potential relationships between systemic drug concentrations/exposure and clinical outcomes, AEs and/or safety parameters. Identify possible covariates which may influence the pharmacokinetics of AZD6244 and/or N-desmethyl AZD6244 To assess the efficacy of AZD6244 vs temozolomide in (i)BRAF* mutation +ve patients and (ii) BRAF and/or NRAS* mutation +ve patients with unresectable AJCC stage 3 or 4 malignant melanoma(*mutational status of BRAF and NRAS in DNA extracted from tumour tissue (fresh or archival)) ; Primary end point(s): The primary objective of this study is to compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by evaluation of: · The primary outcome variable; Progression-free survival (PFS) · The secondary outcome variables; Time to death (TTD), objective response rate (ORR) (based on RECIST) and duration of response | — |
Countries
Austria, Denmark, France, United Kingdom
Outcome results
None listed