Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00338130
First received: June 15, 2006
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma


Condition Intervention Phase
Melanoma
Drug: AZD6244
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients With Unresectable AJCC Stage 3 or 4 Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS) [ Time Frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest) ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest) ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: RECIST data collected as per institutional standard practise ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: RECIST data collected as per institutional standard practise ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the safety and tolerability of AZD6244 [ Time Frame: Assessed at all visits ] [ Designated as safety issue: Yes ]
  • Investigation of the pharmacokinetics of AZD6244 [ Time Frame: Day 1 & 8 (for patients on AZD6244) ] [ Designated as safety issue: Yes ]
  • Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive [ Time Frame: From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest) ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: July 2006
Study Completion Date: July 2013
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Temozolomide
Drug: Temozolomide
oral
Experimental: 2
AZD6244
Drug: AZD6244
Oral liquid or Capsule
Other Name: ARRY-142886

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with late stage malignant melanoma
  • Aged 18 or over
  • Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal

Exclusion Criteria:

  • Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
  • Participation in any other trial with an investigational product within the previous 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338130

  Show 33 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AZD6244 Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00338130     History of Changes
Other Study ID Numbers: D1532C00003, EUDRACT No. 2006-001456-12
Study First Received: June 15, 2006
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Melanoma
Phase II
AZD6244
temozolomide

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

ClinicalTrials.gov processed this record on August 28, 2014