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Trilostane

Phase 2

Prostate Cancer | Small molecule | Oncology |Sanofi|Trials Updated: Dec 3, 2013

Trilostane development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2005

Trilostane target and mechanism

Molecular targetHSD3B2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Trilostane clinical trials

Trilostane · 1 trial · 2 indications

Phase 2 1
NCT00181597Trilostane for Androgen-Independent Prostate CancerProstate Cancer
COMPLETED24 Analytics
PHASE2COMPLETED
Trilostane for Androgen-Independent Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

activity of trilostane in men with androgen-independent prostate cancer.
4 years

Secondary Endpoints

serum levels of gonadal and adrenal steroids
4 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
TrilostaneDRUGTaken orally once a day for three days then twice daily thereafter.
HydrocortisoneDRUGTaken orally with trilostane.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Disease progression despite androgen depravation therapy and antiandrogen withdrawal * Progressive measurable disease or bone scan progression or PSA progression * Serum total testosterone \< 50ng/ml * Creatinine \< 2.0 mg/dl ...

Countries:United States
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Competitive Landscape -Prostate Cancer 417 trials

Top 20 of 55 competitors

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Frequently asked questions about Trilostane

What is Trilostane used for in prostate cancer?

Trilostane is being studied in prostate cancer, specifically androgen-independent prostate cancer and prostate adenocarcinoma. It is an investigational small molecule developed by Sanofi. A Phase 2 trial evaluated it in adult male patients with these conditions. It is not described as an approved treatment for prostate cancer.

What does Trilostane target?

Trilostane targets HSD3B2, also known as 3 beta-hydroxysteroid dehydrogenase type 2. It acts as an inhibitor of this enzyme. By inhibiting HSD3B2, Trilostane affects steroid hormone synthesis, which is the basis for its investigation in hormone-related cancers such as prostate cancer.

Who makes Trilostane?

Sanofi, ticker SNY, is the developer of Trilostane. The company is associated with the drug's clinical development in oncology, including the Phase 2 study in prostate cancer. Sanofi is a global pharmaceutical company.

What phase is Trilostane in?

Trilostane is in Phase 2 clinical development for prostate cancer. One Phase 2 trial has been completed, and no active trials are currently listed. It remains an investigational agent and is not described as FDA approved for this indication.

What clinical trials is Trilostane in?

Trilostane has been studied in one completed Phase 2 trial, NCT00181597, titled "Trilostane for Androgen-Independent Prostate Cancer." The trial enrolled 24 male patients aged 18 years and older in the United States. It was an uncontrolled, non-randomized study.