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Completed

NCT Number: 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

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

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastases, Neoplasm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD4054 10 mg

Drug

1 x 10 mg oral tablets once daily

Other names: Zibotentan,

ZD4054 15 mg

Drug

1 x 10 mg + 2 x 2.5 mg oral tablets once daily

Other names: Zibotentan

ZD4054 22.5 mg

Drug

2 x 10 mg + 2 x 2.5 mg oral tablets once daily

Other names: Zibotentan

Primary outcomes

  1. Dose Limiting Toxicities (DLTs)

    Time frame: Baseline to Day 29.

    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

  1. Total Prostate Specific Antigen (PSA) Concentration

    Time frame: Baseline to Day 15.

    Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient - no dose was administered on Day 2).

  2. Change in Total Prostate Specific Antigen (PSA)

    Time frame: Baseline to Day 15.

    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

  3. Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)

    Time frame: Baseline to Day 15.

    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

  4. Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)

    Time frame: Baseline to Day 15.

    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

  5. Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)

    Time frame: Baseline to Day 15.

    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

  6. Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)

    Time frame: Baseline to Day 15.

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 4, 2003
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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