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Comparator: MK0429

Phase 1

Prostatic Neoplasms | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 27, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00302471MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)PHASE1 COMPLETED 29Mar 1, 2006Oct 1, 2007Apr 27, 2015 -
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Study Endpoints
Primary Endpoints
Safety and tolerability of 4 weeks of MK0429 therapy.
up to 14 days following last dose of medication
Secondary Endpoints
Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429
4 weeks
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1600 mg twice a dayEXPERIMENTALMK0429
200 mg twice a dayEXPERIMENTALMK0429
800 mg twice a dayEXPERIMENTALMK0429
400 mg twice a dayEXPERIMENTALMK0429
Interventions
NameTypeDescription
Comparator: MK0429DRUGPart 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone. Disease.
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo

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 th...

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