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A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00172016
Collaborator
(none)
43
Enrollment
1
Arm

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer

Condition or Disease Intervention/Treatment Phase
  • Drug: Zoledronic acid
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Apr 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: ZOL446 (zoledronic acid)

Drug: Zoledronic acid

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent must be obtained

    • Age > 18 years

    • Histologically confirmed diagnosis of carcinoma of the prostate

    • Current (or previous) objective evidence of metastatic disease to the bone

    • Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments

    • ECOG performance status of 0, 1, or 2

    Exclusion Criteria:

    • Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less

    • Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)

    • WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L.

    • Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.

    • Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.

    • Known hypersensitivity to zoledronic acid or other bisphosphonates

    • Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study

    Other protocol-defined inclusion / exclusion criteria apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00172016
    Other Study ID Numbers:
    • CZOL446EHU01
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Apr 30, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Novartis Pharmaceuticals
    Zoledronic acid
    SRE
    Prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Zoledronic Acid

    Study Results

    No Results Posted as of Apr 30, 2012