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ET743

Phase 2

Breast Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Apr 28, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

ET743 · 1 trial · 5 indications

Phase 2 1
NCT00050427A Study of ET-743 (Trabectedin) in Patients With Advanced Breast CancerBreast Neoplasms
COMPLETED53 Analytics
PHASE2COMPLETED
A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with objective response in each treatment arm.
Up to approximately 52 weeks

Secondary Endpoints

Progression-free survival (PFS)
Up to approximately 52 weeks
Time to progression (TTP)
Up to approximately 52 weeks
Overall survival (OS)
Up to approximately 52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
002EXPERIMENTALET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.

Interventions

NameTypeDescription
ET743DRUG580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of advanced breast cancer * Prior therapy with anthracycline and taxane (2 types of chemotherapy drugs) * At least one measureable tumor lesion * Adequate bone marrow, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1...

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Frequently asked questions about ET743

What is ET743 used for in breast cancer?

ET743, also known as trabectedin, is an investigational small molecule being studied for the treatment of breast neoplasms, or breast cancer. It is in Phase 2 clinical development and has been evaluated in patients with advanced breast cancer.

What does ET743 target?

ET743 is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being studied for its potential anti-cancer activity in breast cancer.

Who makes ET743?

ET743 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.

What phase is ET743 in?

ET743 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not yet approved by regulatory authorities, meaning it remains an investigational drug.

What clinical trials is ET743 in?

ET743 has been studied in one completed clinical trial, NCT00050427, titled 'A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer.' This Phase 2 trial enrolled 53 female patients aged 18 years and older.

Is ET743 the same as trabectedin?

Yes, ET743 is also known as trabectedin. The clinical trial NCT00050427 refers to the drug as ET-743 (Trabectedin), indicating that these names are used interchangeably for the same compound.