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

Phase 1

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00302471
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-10
• Study First Posted: 2006-03-14
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of 4 weeks of MK0429 therapy.	up to 14 days following last dose of medication

Secondary Outcome Measures

Name	Time	Method
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