ZD6474 Phase IIa Dose Finding Multicentre Study | NCT00252746 | Trialant

ZD6474 Phase IIa Dose Finding Multicentre Study | NCT00252746 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZD6474 100mg	Experimental	Daily dose	Drug: ZD6474 (vandetanib) 100mg
ZD6474 200mg	Experimental	daily dose	Drug: ZD6474 (vandetanib) 200mg
ZD6474 300mg	Experimental	daily dose	Drug: ZD6474 (vandetanib) 300mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18379357	Background	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.

Condition Browse Module