MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)
A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease
3 other identifiers
interventional
29
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedApril 27, 2015
April 1, 2015
1.6 years
March 9, 2006
April 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of 4 weeks of MK0429 therapy.
up to 14 days following last dose of medication
Secondary Outcomes (2)
Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429
4 weeks
Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks]
4 weeks and 8 weeks
Study Arms (4)
1600 mg twice a day
EXPERIMENTALMK0429
200 mg twice a day
EXPERIMENTALMK0429
800 mg twice a day
EXPERIMENTALMK0429
400 mg twice a day
EXPERIMENTALMK0429
Interventions
Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone. Disease.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prostate cancer-related bone pain
- Previously received bisphosphonate therapy (e.g. zoledronate)
- Received any investigational treatment within the last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 20398037RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 14, 2006
Study Start
March 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
April 27, 2015
Record last verified: 2015-04