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

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: AZD6244; Drug: Placebo; Drug: Dacarbazine

• Registration Number: NCT00936221
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2011-11
• Disposition First Submitted: 2013-08-22
• Disposition First Submitted QC: 2013-08-22
• Disposition First Posted: 2013-08-30
• Study Completion: 2014-11
• Results First Submitted: 2015-11-04
• Results First Submitted QC: 2015-11-04
• Results First Posted: 2015-12-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo in combination with dacarbazine
1	AZD6244	AZD6244 in combination with dacarbazine
1	Dacarbazine	AZD6244 in combination with dacarbazine
2	Dacarbazine	Placebo in combination with dacarbazine

Primary Outcome Measures

Name	Time	Method
Overall Survival	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	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment	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.
Objective Response Rate	From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment	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
Change in Target Lesion Tumour Size at Week 12	randomization to week 12

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom