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Atrasentan

Phase 3

Prostate Cancer | Small molecule | Oncology |Abbott Laboratories|Last Updated: Feb 21, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment1,166

FDA Designations

No designations recorded

Clinical trial landscape

Atrasentan · 5 trials · 3 indications

Phase 3 3Phase 2 2
NCT00046943Atrasentan in Treating Patients With Prostate CancerProstate Cancer
COMPLETED- Analytics
NCT00036556Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate CancerProstatic Neoplasms
COMPLETED941 Analytics
NCT00036543A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate CancerProstate Cancer
COMPLETED1,000 Analytics
PHASE3COMPLETED
Atrasentan in Treating Patients With Prostate Cancer
Prostate CancerUnlock trial analytics
PHASE3COMPLETED
Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Prostatic NeoplasmsUnlock trial analytics
PHASE3COMPLETED
A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
Every 12 weeks
The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
Adverse events
Every 12 weeks
Serious adverse events
Oncology-related events (OREs)
Deaths
Study drug exposure
Change from baseline in Karnofsky performance status
Vital signs
Stratification by treatment group from prior study

Secondary Endpoints

Safety and laboratory parameters
Every 12 weeks
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Study Design & Arms

MaskingNONE
PurposeTREATMENT

Interventions

NameTypeDescription
atrasentan hydrochlorideDRUG -
AtrasentanDRUG -
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Eligibility Criteria

Age Range19 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: * Diagnosis of hormone-refractory prostate cancer * Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days * Disease progression OR * Active in trial when double-blind treatment period ended PATIENT CHARACTERISTICS: Age * 19 and over Performanc...

Countries:United StatesAustraliaAustriaBelgiumCanadaFranceGermanyGreeceIrelandItalyNetherlandsNew ZealandPolandSouth AfricaSpainSwedenUnited KingdomSwitzerland
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Atrasentan

What is Atrasentan used for?

Atrasentan is an investigational small molecule being studied for the treatment of prostate cancer, including metastatic and non-metastatic hormone-refractory prostate cancer, as well as hormone-naive prostate cancer with early signs of biochemical failure. It is being developed by Abbott Laboratories (NYSE: ABT) and is currently in Phase 3 clinical development.

What does Atrasentan target?

Atrasentan is an endothelin receptor antagonist, targeting the endothelin A receptor. This mechanism is being investigated for its potential role in slowing prostate cancer progression. The drug is being developed by Abbott Laboratories (NYSE: ABT) for the treatment of prostate cancer.

Who makes Atrasentan?

Atrasentan is being developed by Abbott Laboratories, traded on the New York Stock Exchange under the ticker ABT. The company is conducting clinical trials to evaluate the drug for the treatment of prostate cancer, including hormone-refractory and hormone-naive forms of the disease.

What phase is Atrasentan in?

Atrasentan is in Phase 3 clinical development for prostate cancer, specifically for metastatic and non-metastatic hormone-refractory prostate cancer. It has completed three trials, including two Phase 3 studies and two Phase 2 studies, with a total enrollment of 1,166 participants. The drug is investigational and not yet approved.

What clinical trials is Atrasentan in?

Atrasentan has completed several clinical trials, including NCT00036543, a Phase 3 study in men with metastatic hormone-refractory prostate cancer with 1,000 participants, and NCT00036556, a Phase 3 study in non-metastatic hormone-refractory prostate cancer with 941 participants. Additional Phase 2 trials include NCT00038662 and NCT00127478.

Is Atrasentan the same as ABT-627?

Atrasentan is also known as ABT-627, an endothelin receptor antagonist being developed by Abbott Laboratories (NYSE: ABT). It is being studied for the treatment of prostate cancer, including hormone-refractory and hormone-naive forms. The drug is currently in Phase 3 clinical development.