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SR31747A

Phase 2

Prostatic Neoplasm | Small molecule | Oncology |Sanofi|Last Updated: Dec 23, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment232

FDA Designations

No designations recorded

Clinical trial landscape

SR31747A · 1 trial · 1 indication

Phase 2 1
NCT00174863Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate CancerProstatic Neoplasm
COMPLETED232 Analytics
PHASE2COMPLETED
Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
Prostatic NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Time To Clinical Progression assessed by every 4 weeks clinical examination and every 12 weeks radiological examinations (Thoraco-abdominopelvic CT scan ; Bone scan ± centered Bone X-rays, MRI)

Secondary Endpoints

Every 4 weeks: Clinical examination (safety, Tumor related symptoms deterioration), PSA level determination (PSA endpoints), EuroQoL instrument (Quality of Life), Laboratory tests (Hematology, Biochemistry), one PK sample
Every 12 weeks: radiological examinations (tumor response),
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SR31747ADRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Prior confirmed histological diagnosis of prostatic carcinoma. * Rising PSA while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; PSA must be at least 4ng/ml at the tim...

Countries:AustraliaBelgiumCanadaChileCzechiaFranceItalyMexicoNetherlandsPolandPortugalSpainUnited Kingdom
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Frequently asked questions about SR31747A

What is SR31747A used for?

SR31747A is an investigational small molecule being studied for the treatment of prostatic neoplasm, specifically in patients with androgen-independent non-metastatic prostate cancer. It is being developed by Sanofi and has been evaluated in a Phase 2 clinical trial.

Who makes SR31747A?

SR31747A is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is SR31747A in?

SR31747A is in Phase 2 clinical development. It has completed a Phase 2 trial, and the drug remains investigational, meaning it has not been approved by regulatory authorities. Its development status is based on the completed trial data.

What clinical trials is SR31747A in?

SR31747A has been studied in one completed Phase 2 clinical trial, identified as NCT00174863. This trial evaluated SR 31747A versus placebo in androgen-independent non-metastatic prostate cancer and enrolled 232 participants across multiple countries.

Is SR31747A the same as SR 31747A?

Yes, SR31747A and SR 31747A refer to the same drug. The clinical trial record for the drug uses the name SR 31747A, while the drug is also referred to as SR31747A. Both names denote the same investigational small molecule.