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

Purpose

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

Condition	Intervention	Phase
Melanoma	Drug: AZD2644 Drug: Dacarbazine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase II, Double-blind, Randomised Study to Assess the Efficacy of AZD6244 in Combination With Dacarbazine Compared With Dacarbazine Alone in First Line Patients With BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Dacarbazine

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: Overall survival calculated as the interval from date of randomisation to date of patient death (any cause). Patients who have not died at final analysis, or who withdraw consent, will be censored at last date they were known to be alive. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To further assess the efficacy in terms of-Alive and Progression Free at 6 months (APF6)- Progression Free Survival (PFS)- Objective Response Rate (ORR)- Duration of Response (DoR)- Change in tumour size at 12 weeks [ Time Frame: APF6, PFS, ORR, DoR, and change in tumour size at 12 weeks will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 12 and every 12 weeks thereafter relative to randomisation ] [ Designated as safety issue: No ]
To assess the safety and tolerability profile of AZD6244 in combination with dacarbazine [ Time Frame: At every visit (ie weekly for the first 6 weeks and then every 3 weeks) ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetics of AZD6244 [ Time Frame: At Day 1 and Day 22 ] [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2013
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 AZD6244 in combination with dacarbazine	Drug: AZD2644 oral capsules, 75mg twice daily Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC
Placebo Comparator: 2 Placebo in combination with dacarbazine	Drug: Dacarbazine 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle Other Name: DTIC

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936221

Show 38 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Mark Middleton, Dr	Churchil Hospital, Oxford, UK
Principal Investigator:	Caroline Robert, Dr	Institute Gustave Roussy, France
Study Director:	Ian Smith, Dr	AstraZeneca, Alderley Park, UK

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00936221 History of Changes
Other Study ID Numbers:	D1532C00006
Study First Received:	July 8, 2009
Last Updated:	March 19, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

BRAF mutation positive
advanced melanoma
Advanced cutaneous melanoma
Unknown primary melanoma

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013