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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Mesothelioma

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Disease Control.

Outcome Description:

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.

Outcome Time Frame:

Assessed at 2 months.

Safety Issue:

No

Principal Investigator

Rolf Stahel

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Zurich

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

D4200C00075

NCT ID:

NCT00597116

Start Date:

December 2007

Completion Date:

January 2010

Related Keywords:

  • Mesothelioma
  • Mesothelioma
  • inoperable
  • relapsed
  • Mesothelioma

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