Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

AstraZeneca385 enrolled

Overview

To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

385

Conditions

Melanoma

Interventions

AZD6244DRUG

oral capsules, 75mg twice daily

DacarbazineDRUG

1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma * Tumor sample confirmed as BRAF mutation positive Exclusion Criteria: * Diagnosis of uveal or mucosal melanoma * Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK * Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug

Locations (38)

Outcomes

Primary Outcomes

Overall Survival

Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.

Time frame: From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later

Secondary Outcomes

Progression Free Survival

PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

Time frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment

Objective Response Rate

ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR

Time frame: From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment

Change in Target Lesion Tumour Size at Week 12

Time frame: randomization to week 12

Data from ClinicalTrials.gov

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