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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
History of Changes
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
Metastases, Neoplasm
 Drug: ZD4054 10 mg
Drug: ZD4054 15 mg
Drug: ZD4054 22.5 mg
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: June 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZD4054 10 mg
1 x 10 mg oral tablets once daily
 Drug: ZD4054 10 mg
1 x 10 mg oral tablets once daily
Other Name: Zibotentan,
Experimental: ZD4054 15 mg
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
 Drug: ZD4054 15 mg
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
Other Name: Zibotentan
Experimental: ZD4054 22.5 mg
2 x 10 mg + 1 x 2.5 mg oral tablets once daily
 Drug: ZD4054 22.5 mg
2 x 10 mg + 2 x 2.5 mg oral tablets once daily
Other Name: Zibotentan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055471

Locations
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Sponsors and Collaborators
AstraZeneca
  More Information

Additional Information:
AstraZeneca Information Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00055471     History of Changes
Other Study ID Numbers: 4054IL/0004
Study First Received: March 3, 2003
Results First Received: March 29, 2011
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
prostate cancer
Metastatic prostate cancer
bone metastases

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
 Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013