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CEP-11981

Phase 1

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

CEP-11981 target and mechanism

Molecular targetFLT1, FLT4, KDR, TEK
Target classInhibitor
ModalitySmall molecule

Also known as CEP-11981 (kinase inhibitor)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

CEP-11981 clinical trials

CEP-11981 · 1 trial · 1 indication

Phase 1 1
NCT00875264Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced CancerCancer
COMPLETED43 Analytics
PHASE1COMPLETED
Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about CEP-11981

What is CEP-11981?

CEP-11981 is an investigational small molecule kinase inhibitor being developed by Teva Pharmaceutical Industries Limited for the treatment of advanced cancer. It is a Phase 1 oncology candidate and has not been approved for any indication. CEP-11981 is also known as CEP-11981 (kinase inhibitor).

What does CEP-11981 target?

CEP-11981 targets the kinases FLT1, FLT4, KDR, and TEK. As an inhibitor, it acts on these targets, which are receptor tyrosine kinases involved in angiogenesis and vascular signaling. Targeting these kinases is the basis for its investigation in advanced cancer.

Who makes CEP-11981?

CEP-11981 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating this kinase inhibitor in oncology.

What phase is CEP-11981 in?

CEP-11981 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. The Phase 1 program has been completed, with one completed trial and no active trials at this time.

What clinical trials is CEP-11981 in?

CEP-11981 has been studied in one completed Phase 1 trial, NCT00875264. That open-label study was designed to determine the maximum tolerated oral dose of the kinase inhibitor CEP-11981 in patients with advanced cancer, and it enrolled 43 participants.

Is CEP-11981 the same as CEP-11981 (kinase inhibitor)?

Yes, CEP-11981 (kinase inhibitor) is an alternative name for CEP-11981. Both names refer to the same investigational small molecule developed by Teva Pharmaceutical Industries Limited for advanced cancer.