NCT00691899

Brief Summary

The purpose of this study is to investigate the effects of MK0822 in prolonging the time to first bone metastasis in men with castration-resistant prostate cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2008

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 12, 2016

Status Verified

November 1, 2015

Enrollment Period

Same day

First QC Date

June 4, 2008

Last Update Submit

August 11, 2016

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of treatment with MK0822 5 mg once daily on bone metastasis-free survival (i.e., the risk of developing a first bone metastasis or dying from any cause) compared to placebo

    Approximately 36 months (event-driven study)

Secondary Outcomes (1)

  • To assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo

    Approximately 36 months (event-driven study)

Study Arms (2)

1

EXPERIMENTAL
Drug: odanacatib

2

PLACEBO COMPARATOR
Drug: placebo (unspecified)

Interventions

odanacatibDRUG

odanacatib; 5mg oral, once daily for Approximately 36 months.

Also known as: MK0822
1
placebo (unspecified)DRUG

placebo; oral, once daily for Approximately 36 months

2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Castration-resistant prostate cancer; increased risk for prostate cancer progression
  • Patient underwent bilateral orchiectomy 6 months or more (i.e., =180 days) prior to Visit 1, or is receiving androgen-deprivation therapy and is on a stable regimen for at least 3 months (i.e., =90 days) prior to Visit 1. Androgen-deprivation therapy may include gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin

You may not qualify if:

  • Bone metastases or history of bone metastases
  • Patient has other distant metastases (e.g., visceral, including brain, or soft-tissue). Patients with regional lymph nodal metastases are eligible
  • Patient has ANY of the following:
  • currently is receiving a bisphosphonate or other drug therapy for osteoporosis
  • has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to Visit 1, or for a total of more than 6 months at any time prior to Visit 1
  • has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1
  • Patient has a history of any malignancy other than prostate cancer \<5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer. Melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are excluded
  • Patient is currently participating in, or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
  • Patient is currently participating in or has at any time in the past participated in a prostate cancer study with a registered medication (i.e., approved by the regulatory agency in which he resides) being tested for the treatment of prostate cancer (an unapproved indication)
  • Patient is currently using a systemically administered azole antifungal (for example, ketoconazole, fluconazole, itraconazole, miconazole, posaconazole, ravuconazole, and voriconazole). Patients taking these medications must discontinue their use at least one week prior to starting blinded study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 12, 2016

Record last verified: 2015-11