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

Mesothelioma Clinical Trial

Official title:

A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00597116
• Other study ID #: D4200C00075
• Secondary ID: EUDRACT Number 2
• Status: Terminated
• Phase: Phase 2
• First received: January 9, 2008
• Last updated: September 14, 2012
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Mesothelioma

Intervention

Drug:
• Vinorelbine

• Vandetanib
once daily oral dose

Locations

Country	Name	City	State
Germany	Research Site	Essen
Germany	Research Site	Halle-Dolau
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Switzerland	Research Site	Chur
Switzerland	Research Site	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Disease Control.	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.	Assessed at 2 months.	No
Secondary	Number of Participants With Objective Response.	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.	Assessed at 2 months.	No
Secondary	Progression-free Survival (PFS)	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.	Assessed from baseline to 12 months.	No
Secondary	Overall Survival (OS)		Assessed from baseline to 12 months.	No