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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

1 x 10 mg + 2 x 2.5 mg oral tablets once daily

2 x 10 mg + 1 x 2.5 mg oral tablets once daily

The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer

A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects with Metastatic Prostate Cancer

2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Research Site

DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment.
The numbers of patients with a DLT are reported.

Age Continuous

Gender, Male/Female

Race, Customized

Height

Study Specific Characteristic

Weight

One patient received one dose of 22.5 mg and was dose reduced to 15 mg thereafter.  This patient was classified into the 15 mg dose group, except for the single dose pharmacokinetic results (not posted).

Dose Limiting Toxicities (DLTs)

Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).

Total Prostate Specific Antigen (PSA) Concentration

Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). 
Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100

The analysis population includes only patients dosed with ZD4054

Change in Total Prostate Specific Antigen (PSA)

Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100

Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)

Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). 
Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100

Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)

Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100

Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)

Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100

Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)

Period 1: Dose escalation period

Period 2: Extension period

6 of the 22 screened patients were not entered into the study as they did not fulfill the study eligibility criteria.

Arms	Assigned Interventions
Experimental: ZD4054 10 mg 1 x 10 mg oral tablets once daily	Drug: ZD4054 10 mg 1 x 10 mg oral tablets once daily Other Name: Zibotentan,
Experimental: ZD4054 15 mg 1 x 10 mg + 2 x 2.5 mg oral tablets once daily	Drug: ZD4054 15 mg 1 x 10 mg + 2 x 2.5 mg oral tablets once daily Other Name: Zibotentan
Experimental: ZD4054 22.5 mg 2 x 10 mg + 1 x 2.5 mg oral tablets once daily	Drug: ZD4054 22.5 mg 2 x 10 mg + 2 x 2.5 mg oral tablets once daily Other Name: Zibotentan

A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects with Metastatic Prostate Cancer

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

AstraZeneca Information Center

Trial Results Summaries

Contacts

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