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

Phase 2

Terminated

• Conditions: Mesothelioma
• Interventions: Drug: Vinorelbine; Drug: Vandetanib

• Registration Number: NCT00597116
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-17
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-04-27
• Results First Submitted QC: 2012-09-14
• Results First Posted: 2012-10-15
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vinorelbine	Vinorelbine
2	Vandetanib	Vandetanib

Primary Outcome Measures

Name	Time	Method
Number of Participants With Disease Control.	Assessed at 2 months.	Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Assessed from baseline to 12 months.
Progression-free Survival (PFS)	Assessed from baseline to 12 months.	Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.
Number of Participants With Objective Response.	Assessed at 2 months.	Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.

Trial Locations

Locations (1)

Research Site; 🇨🇭 Zurich, Switzerland