An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Diagnosed with mesothelioma

• Previously treated with only one course of chemotherapy for mesothelioma

• No previous treatment with vinorelbine

• No serious heart problems within the last 3 months

Exclusion Criteria:

• Serious abnormal laboratory values

• Severe or uncontrolled disease or condition as judged by the Investigator

• Pregnant or breast-feeding women

• Other cancers within the last 5 years

• Major surgery or radiation therapy within 4 weeks prior to starting study therapy

• Receipt of any investigational agents within 30 days prior to commencing study treatment.