Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

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

ZD4054 10 mg

ZD4054 15 mg

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

ZD4054 22.5 mg

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

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.

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

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

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

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

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

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

AstraZeneca

ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily

ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily

ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily

Total

Overall

Age Continuous

Sex: Female, Male

Caucasian

Black

Oriental

Other

Race/Ethnicity, Customized

Height

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).

Gerard Lynch

Dose Limiting Toxicities (DLTs)

Total Prostate Specific Antigen (PSA) Concentration

The analysis population includes only patients dosed with ZD4054

Spots Global Cancer Trial Database for zd4054 10 mg

Every month we try and update this database with for zd4054 10 mg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.