Back to resultsA 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
Primary Purpose
Prostatic Neoplasms, Metastases, Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZD4054 10 mg
ZD4054 15 mg
ZD4054 22.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate cancer, Metastatic prostate cancer, bone metastases
Eligibility Criteria
Inclusion Criteria: Men 18 years & older Confirmed diagnosis of prostate cancer with bone metastases Exclusion Criteria: No more than 2 prior chemotherapy regimens No radiation, chemotherapy or bisphosphonates in the past 4 weeks
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ZD4054 10 mg
ZD4054 15 mg
ZD4054 22.5 mg
Arm Description
1 x 10 mg oral tablets once daily
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total Prostate Specific Antigen (PSA) Concentration
Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
Change in Total Prostate Specific Antigen (PSA)
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
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
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 Procollagen Type I N Propeptide (PINP)
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 C-Terminal Telopeptide of Type I Collagen (CTx)
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 Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00055471
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Metastases, Neoplasm
Keywords
prostate cancer, Metastatic prostate cancer, bone metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZD4054 10 mg
Arm Type
Experimental
Arm Description
1 x 10 mg oral tablets once daily
Arm Title
ZD4054 15 mg
Arm Type
Experimental
Arm Description
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
Arm Title
ZD4054 22.5 mg
Arm Type
Experimental
Arm Description
2 x 10 mg + 1 x 2.5 mg oral tablets once daily
Intervention Type
Drug
Intervention Name(s)
ZD4054 10 mg
Other Intervention Name(s)
Zibotentan,
Intervention Description
1 x 10 mg oral tablets once daily
Intervention Type
Drug
Intervention Name(s)
ZD4054 15 mg
Other Intervention Name(s)
Zibotentan
Intervention Description
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
Intervention Type
Drug
Intervention Name(s)
ZD4054 22.5 mg
Other Intervention Name(s)
Zibotentan
Intervention Description
2 x 10 mg + 2 x 2.5 mg oral tablets once daily
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLTs)
Description
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.
Time Frame
Baseline to Day 29.
Secondary Outcome Measure Information:
Title
Total Prostate Specific Antigen (PSA) Concentration
Description
Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
Time Frame
Baseline to Day 15.
Title
Change in Total Prostate Specific Antigen (PSA)
Description
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
Time Frame
Baseline to Day 15.
Title
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
Description
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
Time Frame
Baseline to Day 15.
Title
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
Description
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
Time Frame
Baseline to Day 15.
Title
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
Description
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
Time Frame
Baseline to Day 15.
Title
Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
Description
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
Time Frame
Baseline to Day 15.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men 18 years & older
Confirmed diagnosis of prostate cancer with bone metastases
Exclusion Criteria:
No more than 2 prior chemotherapy regimens
No radiation, chemotherapy or bisphosphonates in the past 4 weeks
Facility Information:
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs