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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone

ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study

Research Site

research Site

research site

A Phase II, Double-blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of ZD4054 (Zibotentan) in Combination with Pemetrexed (Alimta®) vs. Pemetrexed Alone in Patients with Non-small Cell Lung Cancer who Have Failed One Prior Platinum-based Chemotherapy Regimen

Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)

Age Continuous

Gender, Male/Female

Time to Death

Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method

Progression-free survival

Overall Study

14 of the 80 enrolled patients were not randomised to treatments groups: 7 patients did not meet one or more of the study inclusion or exclusion criteria, 3 patients failed screening, 2 patients were not included due to investigator decision, 1 patient withdrew consent and 1 patient died.

Arms	Assigned Interventions
Experimental: 1 ZD4054 + Pemetrexed	Drug: ZD4054 10mg oral tablet, once daily Other Name: Zibotentan Drug: Pemetrexed 500mg2/m IV infusion Other Name: Alimta
Placebo Comparator: 2 ZD4054 matched placebo + pemetrexed	Drug: Pemetrexed 500mg2/m IV infusion Other Name: Alimta Drug: Placebo 10mg oral tablet, once daily

ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=365&filename=CSR-D4320C00035.pdf

CSR-D4320C00035.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator