Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Recurrence

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

ZD6474 (vandetanib) 100mg

ZD6474 (vandetanib) 200mg

ZD6474 (vandetanib) 300mg

Clinical Sciences & Operations

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

ZD6474 Phase IIa Dose Finding Multicentre Study

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]

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.

Genzyme, a Sanofi Company

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

pemetrexed

The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.

ZD6474(Vandetanib) + Alimta Combo Study

A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Irinotecan

Leucovorin

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Antidotes

Protective Agents

Trace Elements

5-Fluorouracil

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ZD6474 Phase IIa Dose Finding Multicentre Study	NCT00252746	Non Small Cell ...	ZD6474 (vandeta... ZD6474 (vandeta... ZD6474 (vandeta...	20 Years -	Sanofi
ZD6474 Phase IIa Dose Finding Multicentre Study	NCT00252746	Non Small Cell ...	ZD6474 (vandeta... ZD6474 (vandeta... ZD6474 (vandeta...	20 Years -	Sanofi
ZD6474(Vandetanib) + Alimta Combo Study	NCT00506051	Carcinoma Non-Small Cell ... Lung Cancer	ZD6474 (vandeta... pemetrexed ZD6474 (vandeta...	18 Years -	Sanofi
ZD6474(Vandetanib) + Alimta Combo Study	NCT00506051	Carcinoma Non-Small Cell ... Lung Cancer	ZD6474 (vandeta... pemetrexed ZD6474 (vandeta...	18 Years -	Sanofi
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination	NCT00507091	Metastatic Colorectal Adenocarcinoma	ZD6474 (vandeta... Irinotecan 5-Fluorouracil Leucovorin ZD6474 (vandeta...	18 Years -	Sanofi
ZD6474 Phase IIa Dose Finding Multicentre Study	NCT00252746	Non Small Cell ...	ZD6474 (vandeta... ZD6474 (vandeta... ZD6474 (vandeta...	20 Years -	Sanofi

Spots Global Cancer Trial Database for zd6474 (vandetanib) 300mg