Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00338130

Collaborator

(none)

239

Enrollment

Locations

Arms

Duration (Months)

7.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: AZD6244 Drug: Temozolomide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

239 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Temozolomide	Drug: Temozolomide oral
Experimental: 2 AZD6244	Drug: AZD6244 Oral liquid or Capsule Other Names: ARRY-142886

Arm

Intervention/Treatment

Active Comparator: 1

Temozolomide

Drug: Temozolomide

oral

Experimental: 2

AZD6244

Drug: AZD6244

Oral liquid or Capsule

Other Names:

ARRY-142886

Outcome Measures

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) [From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)]
Time to death [From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)]
Objective Response Rate [RECIST data collected as per institutional standard practise]
Duration of response [RECIST data collected as per institutional standard practise]

Secondary Outcome Measures

Assessment of the safety and tolerability of AZD6244 [Assessed at all visits]
Investigation of the pharmacokinetics of AZD6244 [Day 1 & 8 (for patients on AZD6244)]
Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive [From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	Santa Monica	California	United States
2	Research Site	Aurora	Colorado	United States
3	Research Site	Miami Beach	Florida	United States
4	Research Site	Niles	Illinois	United States
5	Research Site	Boston	Massachusetts	United States
6	Research Site	Buffalo	New York	United States
7	Research Site	New York	New York	United States
8	Research Site	Oklahoma City	Oklahoma	United States
9	Research Site	Pittsburgh	Pennsylvania	United States
10	Research Site	Nashville	Tennessee	United States
11	Research Site	Ciudad de Buenos Aires		Argentina
12	Research Site	Vicente Lopez		Argentina
13	Research Site	Heidelberg		Australia
14	Research Site	Nedlands		Australia
15	Research Site	Waratah		Australia
16	Research Site	St. Pölten		Austria
17	Research Site	Wien		Austria
18	Research Site	Belo Horizonte		Brazil
19	Research Site	Curitiba		Brazil
20	Research Site	Goiânia		Brazil
21	Research Site	Porto Alegre		Brazil
22	Research Site	Salvador		Brazil
23	Research Site	São Paulo		Brazil
24	Research Site	Oshawa	Ontario	Canada
25	Research Site	Montreal	Quebec	Canada
26	Research Site	Odense		Denmark
27	Research Site	Boulogne Billancourt		France
28	Research Site	Nantes Cedex 1		France
29	Research Site	Villejuif Cedex		France
30	Research Site	Zürich		Switzerland
31	Research Site	Glasgow		United Kingdom
32	Research Site	London		United Kingdom
33	Research Site	Oxford		United Kingdom