Skip to main content
OpenTrials
Completed

NCT Number: NCT00302471

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK0429

Drug

Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone.

Disease.

Primary outcomes

  1. Safety and tolerability of 4 weeks of MK0429 therapy.

    Time frame: up to 14 days following last dose of medication

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 14, 2006
Registry last updated
Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.