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

Sponsor
Genzyme, a Sanofi Company
Study ID
NCT00597116
Phase
PHASE2
Status
Terminated

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
  • Vandetanib — DRUG
    once daily oral dose

Study Details

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.

Key Dates

Start date
Dec 31, 2007
Status verified
Aug 2016
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Vinorelbine
  • Experimental: 2
    Vandetanib

Primary Outcome Measure

Number of Participants With Disease Control. [ Time Frame: Assessed at 2 months. ]

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