NCT00055471 — 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 · CancerIndex

Clinical trial · Interventional

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

NCT00055471CI-TRIAL-00008375completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastases, Neoplasm	—	UNRESOLVED	—
Prostatic Neoplasms	Prostate Neoplasm	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
ZD4054 10 mg	Drug	—	UNRESOLVED
ZD4054 15 mg	Drug	—	UNRESOLVED
ZD4054 22.5 mg	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
ZD4054 10 mg
description
1 x 10 mg oral tablets once daily
interventionNames
1. Drug: ZD4054 10 mg
type
EXPERIMENTAL
label
ZD4054 15 mg
description
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
interventionNames
1. Drug: ZD4054 15 mg
type
EXPERIMENTAL
label
ZD4054 22.5 mg
description
2 x 10 mg + 1 x 2.5 mg oral tablets once daily
interventionNames

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jun 1, 2003
Primary completion: Oct 1, 2005
Completion: Oct 1, 2005
First posted: Mar 4, 2003
Last update posted: Oct 31, 2012
Results first posted: Aug 31, 2012
Enrollment: 22 (actual)
Lead sponsor: AstraZeneca INDUSTRY
Keywords: prostate cancer, Metastatic prostate cancer, bone metastases

Data updated 22 days agoSource updated Oct 31, 2012source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.

Primary outcomes (1)

measure
Dose Limiting Toxicities (DLTs)
timeFrame
Baseline to Day 29.
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.

Secondary outcomes (6)

measure
Total Prostate Specific Antigen (PSA) Concentration
timeFrame
Baseline to Day 15.
description
Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).
measure
Change in Total Prostate Specific Antigen (PSA)
timeFrame
Baseline to Day 15.
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
measure
Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)
timeFrame
Baseline to Day 15.
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
measure
Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)
timeFrame
Baseline to Day 15.
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
measure
Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)
timeFrame
Baseline to Day 15.
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
measure
Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)
timeFrame
Baseline to Day 15.
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