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

NCT ID: NCT00302471

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-10-31

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1600 mg twice a day

MK0429

Group Type: EXPERIMENTAL

Comparator: MK0429

Intervention Type: 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.

200 mg twice a day

MK0429

Group Type: EXPERIMENTAL

Comparator: MK0429

Intervention Type: DRUG

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

800 mg twice a day

MK0429

Group Type: EXPERIMENTAL

Comparator: MK0429

Intervention Type: DRUG

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

400 mg twice a day

MK0429

Group Type: EXPERIMENTAL

Comparator: MK0429

Intervention Type: DRUG

Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Comparator: MK0429

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 hormone-refractory prostate cancer and bone metastases. Asia Pac J Clin Oncol. 2010 Mar;6(1):42-8. doi: 10.1111/j.1743-7563.2009.01266.x.

Reference Type: RESULT

PMID: 20398037 (View on PubMed)

Other Identifiers

MK0429-011

Identifier Type: -

Identifier Source: secondary_id

2006_013

Identifier Type: -

Identifier Source: secondary_id

0429-011

Identifier Type: -

Identifier Source: org_study_id