Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
Drug: Comparator: MK0429
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1600 mg twice a day
MK0429
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.

Experimental: 200 mg twice a day
MK0429
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.
Experimental: 800 mg twice a day
MK0429
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.
Experimental: 400 mg twice a day
MK0429
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302471

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00302471     History of Changes
Other Study ID Numbers: 2006_013, MK0429-011
Study First Received: March 9, 2006
Last Updated: January 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bone Diseases
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014