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MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00302471
First received: March 9, 2006
Last updated: January 4, 2010
Last verified: January 2010

March 9, 2006
January 4, 2010
March 2006
October 2007   (final data collection date for primary outcome measure)
Safety and tolerability of 4 weeks of MK0429 therapy. [ Time Frame: up to 14 days following last dose of medication ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00302471 on ClinicalTrials.gov Archive Site
  • Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks] [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease
A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease

This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostatic Neoplasms
  • Drug: Comparator: MK0429

    Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone.

    Disease.

  • Drug: Comparator: MK0429
    Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
  • Drug: Comparator: MK0429
    Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
  • Drug: Comparator: MK0429
    Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
  • Experimental: 1600 mg twice a day
    MK0429
    Intervention: Drug: Comparator: MK0429
  • Experimental: 200 mg twice a day
    MK0429
    Intervention: Drug: Comparator: MK0429
  • Experimental: 800 mg twice a day
    MK0429
    Intervention: Drug: Comparator: MK0429
  • Experimental: 400 mg twice a day
    MK0429
    Intervention: Drug: Comparator: MK0429
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible patients must have:

    • Prostate cancer
    • Bone metastases without symptoms
    • Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression

Exclusion Criteria:

  • Prostate cancer-related bone pain
  • Previously received bisphosphonate therapy (e.g. zoledronate)
  • Received any investigational treatment within the last 30 days
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00302471
2006_013, MK0429-011
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2010

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