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
  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:


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:
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 April 21, 2014