Back to resultsMK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: MK0429
Comparator: MK0429
Comparator: MK0429
Comparator: MK0429
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1600 mg twice a day
200 mg twice a day
800 mg twice a day
400 mg twice a day
Arm Description
MK0429
MK0429
MK0429
MK0429
Outcomes
Primary Outcome Measures
Safety and tolerability of 4 weeks of MK0429 therapy.
Secondary Outcome Measures
Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429
Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00302471
Brief Title
MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1600 mg twice a day
Arm Type
Experimental
Arm Description
MK0429
Arm Title
200 mg twice a day
Arm Type
Experimental
Arm Description
MK0429
Arm Title
800 mg twice a day
Arm Type
Experimental
Arm Description
MK0429
Arm Title
400 mg twice a day
Arm Type
Experimental
Arm Description
MK0429
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0429
Intervention Description
Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone.
Disease.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0429
Intervention Description
Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0429
Intervention Description
Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0429
Intervention Description
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 Measure Information:
Title
Safety and tolerability of 4 weeks of MK0429 therapy.
Time Frame
up to 14 days following last dose of medication
Secondary Outcome Measure Information:
Title
Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429
Time Frame
4 weeks
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20398037
Citation
Rosenthal MA, Davidson P, Rolland F, Campone M, Xue L, Han TH, Mehta A, Berd Y, He W, Lombardi A. Evaluation of the safety, pharmacokinetics and treatment effects of an alpha(nu)beta(3) integrin inhibitor on bone turnover and disease activity in men with hormone-refractory prostate cancer and bone metastases. Asia Pac J Clin Oncol. 2010 Mar;6(1):42-8. doi: 10.1111/j.1743-7563.2009.01266.x.
Results Reference
result
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MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)
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