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A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK0822 (Odanacatib) in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK0822 (Odanacatib) in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer


Merck Duration of Treatment : odanacatib; approximately 36 months (even driven study) -
Comparator Duration of Treatment : placebo (unspecified); approximately 36 months (event
driven study)


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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:

1. currently is receiving a bisphosphonate or other drug therapy for osteoporosis

2. 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

3. has been treated with an intravenous bisphosphonate within the 12 months prior
to Visit 1

- Patient has received chemotherapy within the 2 years prior to Visit 1 (for example,
doxorubicin, cytoxan, estramustine, paclitaxel, docetaxel, etoposide, vinblastine,
5-fluorouracil, interferon, mitoxantrone). This exclusion criterion does not include
androgen-deprivation therapy (e.g., gonadotropin-releasing hormone agonists such as
leuprolide, goserelin, or triptorelin)

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Approximately 36 months (event-driven study)

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2008_527

NCT ID:

NCT00691899

Start Date:

Completion Date:

August 2008

Related Keywords:

  • Prostate Cancer
  • Neoplasm Metastasis
  • Prostatic Neoplasms

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