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Trilostane

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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 254 trials

Frequently asked questions about Trilostane

What is Trilostane used for in prostate cancer?

Trilostane is an investigational small molecule being studied for the treatment of prostate cancer, specifically androgen-independent prostate cancer and prostate adenocarcinoma. It is in Phase 2 clinical development for this indication. The drug is not approved and remains under investigation.

Who makes Trilostane?

Trilostane is being developed by Sanofi, a company traded under the ticker symbol SNY. The drug is currently in Phase 2 clinical development for prostate cancer.

What phase is Trilostane in?

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

What clinical trials is Trilostane in?

Trilostane has one completed clinical trial, NCT00181597, titled "Trilostane for Androgen-Independent Prostate Cancer." This Phase 2 study enrolled 24 male participants aged 18 years and older in the United States and was not randomized, double-blind, or controlled.

Is Trilostane FDA approved?

Trilostane is not FDA approved for prostate cancer. It is an investigational drug currently in Phase 2 clinical development. A completed Phase 2 trial (NCT00181597) evaluated its use in androgen-independent prostate cancer, but approval status has not been established.