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

Prostatic Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302471
• Other study ID #: 0429-011
• Secondary ID: MK0429-0112006_0
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2006
• Last updated: April 24, 2015
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases
• Prostatic Neoplasms

Intervention

Drug:
• Comparator: 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.
• Comparator: MK0429
Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
• Comparator: MK0429
Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.
• Comparator: MK0429
Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of 4 weeks of MK0429 therapy.		up to 14 days following last dose of medication	Yes
Secondary	Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429		4 weeks	No
Secondary	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	No