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Comparator: ridaforolimus + dalotuzumab

Phase 1

Neoplasms | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Feb 10, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment87
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00730379A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)PHASE1 COMPLETED 87Jul 1, 2008Nov 1, 2010Feb 10, 2015 -
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Study Endpoints
Primary Endpoints
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
MTD from Day 1 to Day 28 in Cycle 1 for disease progression
Secondary Endpoints
To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab
At prescribed timepoints as defined in the protocol
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALridaforolimus (MK8669) + dalotuzumab (MK0646)
Interventions
NameTypeDescription
Comparator: ridaforolimus + dalotuzumabDRUGStarting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist * In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must hav...

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