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CEP-11981

Phase 1

Cancer | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Jul 25, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00875264Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced CancerPHASE1 COMPLETED 43Sep 1, 2007Jun 1, 2011Jul 25, 2012 -
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Study Endpoints
Primary Endpoints
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CEP-11981, as defined in the Study Protocol.
At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
Secondary Endpoints
Tumor response or progression using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
Measurement of Pharmacokinetic parameters
Cycle 1 (42 days) and Day 1 of Cycle 2
Safety and tolerability of CEP-11981
At least one 6-week (42-day) cycle, which includes 28 days treatment during each cycle
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAt least one 6-week (42-day) cycle in which patients will be treated daily with CEP-11981 for 28 days, followed by a treatment-free period of 14 days.
Interventions
NameTypeDescription
CEP-11981 (kinase inhibitor)DRUGPatients will be treated with oral CEP-11981 once daily for 28 days, followed by a treatment-free period of 14 days. This 42-day (6-week) period will constitute 1 cycle. The starting dose for the study will be 3 mg/m2. Dose escalation from this starting dose follows a modified Fibonacci sequence.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: The patient: * has a histologically or cytologically confirmed solid tumor that has relapsed or is refractory. Additionally, the tumor must be considered unresponsive or poorly responsive to accepted treatment modalities. * has a life expectancy of at least 12 weeks. * has ...

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