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CEP-37440

Phase 1

Solid Tumors | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Trials Updated: Nov 12, 2021

CEP-37440 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2013

CEP-37440 target and mechanism

Molecular targetALK, PTK2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

CEP-37440 clinical trials

CEP-37440 · 1 trial · 1 indication

Phase 1 1
NCT01922752To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid TumorsSolid Tumors
COMPLETED32 Analytics
PHASE1COMPLETED
To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
8 months

Secondary Endpoints

Time to Response (TTR)
8 months
Number of participants with adverse events
From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
Time to Progression (TTP)
8 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CEP-37440EXPERIMENTAL -

Interventions

NameTypeDescription
CEP-37440DRUGCEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily. Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy. * Patients must have evidence of recurrent, locally advanced, or metastatic d...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about CEP-37440

What is CEP-37440 used for?

CEP-37440 is an investigational small molecule being studied for the treatment of advanced or metastatic solid tumors. It was evaluated in a Phase 1 clinical trial in adult patients with solid tumors. It is not approved for any indication and remains in clinical development.

What does CEP-37440 target?

CEP-37440 targets ALK and PTK2 (also known as FAK). It is a small molecule inhibitor of both kinases. Targeting ALK and PTK2 is intended to interfere with signaling pathways involved in tumor growth and survival.

Who is developing CEP-37440?

CEP-37440 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating CEP-37440 in solid tumors.

What phase is CEP-37440 in?

CEP-37440 is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is CEP-37440 in?

CEP-37440 was studied in a single Phase 1 trial, NCT01922752, titled "To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors." The trial enrolled 32 patients in the United States and is completed.

Is CEP-37440 biomarker-selected?

Yes, the CEP-37440 Phase 1 trial NCT01922752 was biomarker-selected, meaning patient enrollment was guided by specific biomarkers. The trial evaluated oral CEP-37440 in adults with advanced or metastatic solid tumors and completed with 32 participants.