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
1 other identifier
interventional
22
1 country
2
Brief Summary
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2003
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2003
CompletedFirst Posted
Study publicly available on registry
March 4, 2003
CompletedStudy Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedResults Posted
Study results publicly available
August 31, 2012
CompletedOctober 31, 2012
October 1, 2012
2.3 years
March 3, 2003
March 29, 2011
October 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicities (DLTs)
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.
Baseline to Day 29.
Secondary Outcomes (6)
Total Prostate Specific Antigen (PSA) Concentration
Baseline to Day 15.
Change in Total Prostate Specific Antigen (PSA)
Baseline to Day 15.
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
Baseline to Day 15.
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
Baseline to Day 15.
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
Baseline to Day 15.
- +1 more secondary outcomes
Study Arms (3)
ZD4054 10 mg
EXPERIMENTAL1 x 10 mg oral tablets once daily
ZD4054 15 mg
EXPERIMENTAL1 x 10 mg + 2 x 2.5 mg oral tablets once daily
ZD4054 22.5 mg
EXPERIMENTAL2 x 10 mg + 1 x 2.5 mg oral tablets once daily
Interventions
2 x 10 mg + 2 x 2.5 mg oral tablets once daily
Eligibility Criteria
You may qualify if:
- Men 18 years \& older
- Confirmed diagnosis of prostate cancer with bone metastases
You may not qualify if:
- No more than 2 prior chemotherapy regimens
- No radiation, chemotherapy or bisphosphonates in the past 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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).
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2003
First Posted
March 4, 2003
Study Start
June 1, 2003
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
October 31, 2012
Results First Posted
August 31, 2012
Record last verified: 2012-10