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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: Comparator: MK0429

Study type: Interventional

Funder types: Industry

Identifiers

NCT00302471

MK0429-011

0429-011

2006_013

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 4 patient groups

1600 mg twice a day

Experimental group

Description:

MK0429

Treatment:

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

200 mg twice a day

Experimental group

Description:

MK0429

Treatment:

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

800 mg twice a day

Experimental group

Description:

MK0429

Treatment:

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

400 mg twice a day

Experimental group

Description:

MK0429

Treatment:

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429

Drug: Comparator: MK0429