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MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)

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ClinicalTrials.gov Identifier: NCT00302471
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Comparator: MK0429 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Safety and tolerability of 4 weeks of MK0429 therapy. [ Time Frame: up to 14 days following last dose of medication ]

Secondary Outcome Measures :
  1. Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429 [ Time Frame: 4 weeks ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302471


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00302471     History of Changes
Other Study ID Numbers: 0429-011
MK0429-011
2006_013
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Bone Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Musculoskeletal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs