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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

Matching placebo oral tablet once daily, with best supportive care

ZD4054 10 mg oral tablet once daily, with best supportive care

ZD4054 15 mg oral tablet once daily, with best supportive care

This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients with Prostate Cancer and Bone Metastases who have Rising Serum Prostate Specific Antigen (PSA)

Cancer Study Locator (US and Canada Only)

Research Site

Research site

Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly symptomatic Patients with Prostate Cancer and Bone Metastases who have Rising Serum Prostate Specific Antigen (PSA)

Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.

Age Continuous

Gender, Male/Female

Race, Customized

Ethnicity, Customized

‘Final analysis’ results (data cut-off 18th December 2008) should be considered in context with the longevity of the follow-up (median duration approximately 22 months) relative to only approximately 4 months median duration of study treatment.

Time to Progression (TTP)

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

Time to Death

Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.

The analysis population only includes patients with baseline and Week 12 PSA measurements

Change in Total Prostate Specific Antigen (PSA) over Time

Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.

Only patients with measurable disease at the baseline were included in the analysis.

Objective Response Rate (ORR)

Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.

Change in Number of Bone Metastases over Time

Overall Study

135 of the 447 enrolled patients were not randomised to treatments groups: 126 failed screening and 9 did not meet one or more of the study inclusion or exclusion criteria.

Arms	Assigned Interventions
Placebo Comparator: Placebo Matching placebo oral tablet once daily, with best supportive care	-
Experimental: ZD4054 10 mg ZD4054 10 mg oral tablet once daily, with best supportive care	Drug: ZD4054 10 mg 10mg oral tablet once daily Other Name: (Zibotentan)
Experimental: ZD4054 15 mg ZD4054 15 mg oral tablet once daily, with best supportive care	Drug: ZD4054 15 mg 15 mg oral tablet once daily Other Name: Zibotentan

ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients with Prostate Cancer and Bone Metastases who have Rising Serum Prostate Specific Antigen (PSA)

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

Cancer Study Locator (US and Canada Only)

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator