Trial Information
An Open Label Study to Determine the Effect of Avastin in Combination With Dacarbazine on Overall Response Rate in Patients With Unresectable/Metastatic Melanoma
Inclusion Criteria:
- adult patients, >=18 years of age;
- cutaneous malignant melanoma;
- clinical evidence of metastatic disease and/or unresectable regional lymphatic
disease and/or extensive in transit recurrent disease;
- measurable lesions.
Exclusion Criteria:
- prior interferon alfa and/or cytokine therapy for metastatic disease;
- prior chemotherapy for metastatic disease;
- brain metastases;
- chronic daily treatment with high dose aspirin (>325mg/day);
- other coexisting malignancies, or malignancies diagnosed within the past 5 years,
other then basal cell cancer or cervical cancer in situ.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (complete and partial responses), tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI)
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML18727
NCT ID:
NCT01164007
Start Date:
June 2006
Completion Date:
December 2012
Related Keywords:
- Malignant Melanoma
- Melanoma