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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00302471

Enrollment

Registered

2006-03-14

Start date

2006-03-31

Completion date

2007-10-31

Last updated

2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

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.

Interventions

DRUGComparator: 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026