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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00055471
First received: March 3, 2003
Last updated: October 23, 2012
Last verified: October 2012

March 3, 2003
October 23, 2012
June 2003
October 2005   (final data collection date for primary outcome measure)
Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to Day 29. ] [ Designated as safety issue: Yes ]

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.

Not Provided
Complete list of historical versions of study NCT00055471 on ClinicalTrials.gov Archive Site
  • Total Prostate Specific Antigen (PSA) Concentration [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Day 15. ] [ Designated as safety issue: No ]
    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
Not Provided
Not Provided
Not Provided
 
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
Not Provided

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

Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
  • Prostatic Neoplasms
  • Metastases, Neoplasm
  • Drug: ZD4054 10 mg
    1 x 10 mg oral tablets once daily
    Other Name: Zibotentan,
  • Drug: ZD4054 15 mg
    1 x 10 mg + 2 x 2.5 mg oral tablets once daily
    Other Name: Zibotentan
  • Drug: ZD4054 22.5 mg
    2 x 10 mg + 2 x 2.5 mg oral tablets once daily
    Other Name: Zibotentan
  • Experimental: ZD4054 10 mg
    1 x 10 mg oral tablets once daily
    Intervention: Drug: ZD4054 10 mg
  • Experimental: ZD4054 15 mg
    1 x 10 mg + 2 x 2.5 mg oral tablets once daily
    Intervention: Drug: ZD4054 15 mg
  • Experimental: ZD4054 22.5 mg
    2 x 10 mg + 1 x 2.5 mg oral tablets once daily
    Intervention: Drug: ZD4054 22.5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055471
4054IL/0004
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP