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

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Genzyme

Status and phase

Terminated
Phase 2

Conditions

Mesothelioma

Treatments

Drug: Vandetanib
Drug: Vinorelbine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00597116
D4200C00075
EUDRACT Number 2007-003633-16

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

25 participants in 2 patient groups

1
Active Comparator group
Description:
Vinorelbine
Treatment:
Drug: Vinorelbine
2
Experimental group
Description:
Vandetanib
Treatment:
Drug: Vandetanib

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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