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CEP-11981

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about CEP-11981

What is CEP-11981 used for?

CEP-11981 is an investigational small molecule being studied for the treatment of cancer. It is a kinase inhibitor that was evaluated in patients with advanced cancer. The drug is in Phase 1 clinical development and is not yet approved for any use.

How does CEP-11981 work?

CEP-11981 is a kinase inhibitor, meaning it works by blocking the activity of certain kinase enzymes that are involved in cancer cell growth and survival. By inhibiting these targets, the drug aims to slow or stop the progression of tumors in patients with advanced cancer.

Who is developing CEP-11981?

CEP-11981 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is currently in Phase 1 clinical development for the treatment of cancer.

What phase is CEP-11981 in?

CEP-11981 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for safety and tolerability in patients with advanced cancer.

What clinical trials is CEP-11981 in?

CEP-11981 has one completed clinical trial, registered under NCT00875264. This was an open-label, uncontrolled study designed to determine the maximum tolerated oral dose of CEP-11981 in patients with advanced cancer. The trial enrolled 43 participants.