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ARD6562, Docetaxel

Phase 2

Prostatic Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Mar 27, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

ARD6562, Docetaxel · 1 trial · 1 indication

Phase 2 1
NCT00291005PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With PrednisoloneProstatic Neoplasms
COMPLETED42 Analytics
PHASE2COMPLETED
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
Prostatic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)

Secondary Endpoints

Overall response rate by modified WHO criteria, PSA response rate, safety
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
ARD6562, DocetaxelDRUG -
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Eligibility Criteria

Age Range20 Years to 74 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy. Exclusion Criteria: * 1.Body temperature \> 38 degree centigrade. * 2.Prior radiotherapy to \> 25% of bone marrow. * 3.Prior isotope ther...

Countries:Japan
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Frequently asked questions about ARD6562, Docetaxel

What is ARD6562 used for?

ARD6562 is a small molecule being studied for the treatment of prostatic neoplasms, specifically metastatic hormone refractory prostate cancer. It is used in combination with prednisolone. The drug is currently in Phase 2 clinical development and is considered investigational.

Who makes ARD6562?

ARD6562 is being developed by Sanofi, a company traded under the ticker SNY. The drug is in Phase 2 clinical development for the treatment of prostatic neoplasms.

What phase is ARD6562 in?

ARD6562 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed.

What clinical trials is ARD6562 in?

ARD6562 has one completed clinical trial, identified as NCT00291005. This was a Phase 2, open-label, non-comparative trial in metastatic hormone refractory prostate cancer, combining the drug with prednisolone. The trial enrolled 42 male participants in Japan.

Is ARD6562 the same as docetaxel?

ARD6562 is also known as docetaxel. It is a small molecule being developed by Sanofi for the treatment of prostatic neoplasms, specifically metastatic hormone refractory prostate cancer.