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

Merck Sharp & Dohme LLC29 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

Comparator: MK0429DRUG

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

Comparator: MK0429DRUG

Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.

Comparator: MK0429DRUG

Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety and tolerability of 4 weeks of MK0429 therapy.

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

Secondary Outcomes

Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429

Time frame: 4 weeks

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

Data from ClinicalTrials.gov

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