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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00936221
First received: July 8, 2009
Last updated: July 3, 2014
Last verified: July 2014

July 8, 2009
July 3, 2014
July 2009
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00936221 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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-Alive and Progression Free at 6 months (APF6)- Pr [ 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 ]
Not Provided
Not Provided
 
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Melanoma
  • 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
  • Drug: Placebo
    Placebo
  • Active Comparator: 1
    AZD6244 in combination with dacarbazine
    Interventions:
    • Drug: AZD2644
    • Drug: Dacarbazine
  • Placebo Comparator: 2
    Placebo in combination with dacarbazine
    Interventions:
    • Drug: Dacarbazine
    • Drug: Placebo
Robert C, Dummer R, Gutzmer R, Lorigan P, Kim KB, Nyakas M, Arance A, Liszkay G, Schadendorf D, Cantarini M, Spencer S, Middleton MR. Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study. Lancet Oncol. 2013 Jul;14(8):733-40. doi: 10.1016/S1470-2045(13)70237-7. Epub 2013 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
385
September 2014
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Czech Republic,   France,   Germany,   Hungary,   Netherlands,   Norway,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00936221
D1532C00006
Not Provided
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP