ZD6474 Phase IIa Dose Finding Multicentre Study

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252746
• Other study ID #: D4200C00039
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: August 24, 2016
• Start date: December 2004
• Est. completion date: January 2007

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Provision of written informed consent.

• Life expectancy of 12 weeks or longer.

Exclusion Criteria:

• Pregnancy, breast feeding or female patients wishing to become pregnant.

• Treatment with a non-approved or investigational drug within 30 days before enrolment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Drug:
• ZD6474 (vandetanib) 100mg
once daily oral dose
• ZD6474 (vandetanib) 200mg
once daily oral dose
• ZD6474 (vandetanib) 300mg
once daily oral dose

Locations

Country	Name	City	State
Japan	Research Site	Isehara	Kanagawa
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Okayama
Japan	Research Site	Osakasayama	Osaka
Japan	Research Site	Sunto-gun	Shizuoka
Japan	Research Site	Tokyo
Japan	Research Site	Toyonaka	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kiura K, Nakagawa K, Shinkai T, Eguchi K, Ohe Y, Yamamoto N, Tsuboi M, Yokota S, Seto T, Jiang H, Nishio K, Saijo N, Fukuoka M. A randomized, double-blind, phase IIa dose-finding study of Vandetanib (ZD6474) in Japanese patients with non-small cell lung cancer. J Thorac Oncol. 2008 Apr;3(4):386-93. doi: 10.1097/JTO.0b013e318168d228. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively		Every 4 weeks for the first 24 weeks of treatment and then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response	No
Secondary	To assess the tolerability, safety, disease control rate, duration of response, time to progression, changes in quality of life and tumour-related and overall symptom improvements, and to characterise the PK and PK-PD relationship	Tumour assessments to evaluate disease control rate, duration of response, time to progression will be performed every 4 weeks for the first 24 weeks of treatment, then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response. Quality of life questionnaire - FACT-L will be given to subjects at baseline and at 4-week intervals during the study treatment (up to Week 12). Lung cancer subscale (LCS) for disease-related symptoms collection will be completed weekly (up to Week 12). Safety and tolerability will be assessed on the ongoing basis by AZ collection, and at the site visits by vital sign, ECG and lab assessments. Blood sampling for pharmacokinetics will be performed on day 8, 15, 22, 29, 57 and 85. In the event of QTc prolongation, PK sampling will continue with the additional ECG monitoring performed until the QTc has fallen below 460 msec.	Every 4 weeks till meeting discontinuation criteria	Yes