Trial information
A Study of Avastin (Bevacizumab) in Combination With Dacarbazine in Patients With Unresectable/Metastatic Melanoma.
Status: Recruiting
Protocol number: ML18727
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: An open label study to determine the effect of Avastin in combination with dacarbazine on overall response rate in patients with unresectable/metastatic melanoma
Brief summary: This study will assess the preliminary antitumor activity and safety profile of a combination of Avastin and dacarbazine in patients with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease. Patients will receive Avastin 10mg/kg iv on days 1 and 14, and dacarbazine 800mg/m² on days 1 and 28, of every 28 day cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 36.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Malignant Melanoma
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Overall response rate (complete and partial responses).
Key secondary outcomes: 1. Efficacy: Duration of response, time to progression, time to treatment failure, overall survival. Safety: Adverse events, laboratory parameters.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2006
Trial registration date: 10/17/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
