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Glucocorticoid

Phase 1

Prostate Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Apr 19, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Glucocorticoid · 1 trial · 1 indication

Phase 1 1
NCT01664728An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001Prostate Neoplasms
COMPLETED54 Analytics
PHASE1COMPLETED
An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001
Prostate NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
Overall survival
every 3 months up to 3 years after study entry

Secondary Endpoints

Number of participants with adverse events
up to 30 days after the last dose of study medication
Time to disease progression
every 3 months up to 3 years after study entry
Time to prostate specific antigen progression
every 3 months up to 3 years after study entry
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Abiraterone acetateEXPERIMENTAL -

Interventions

NameTypeDescription
Abiraterone acetateDRUGPhase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
GlucocorticoidDRUGprednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Completed 12 cycles of abiraterone acetate under study COU-AA-001 * Last dose of abiraterone acetate within 14 days prior to treatment in this study * Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment * Serum potassium level \>=3.5 mm...

Countries:United Kingdom
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Frequently asked questions about Glucocorticoid

What is Glucocorticoid used for in prostate neoplasms?

Glucocorticoid is an investigational small molecule being studied for the treatment of prostate neoplasms, a type of cancer. It is currently in Phase 1 clinical development. The drug is being evaluated in patients with advanced prostate cancer who have completed a prior clinical study.

Who makes Glucocorticoid?

Glucocorticoid is being developed by Johnson & Johnson, a pharmaceutical company listed on the stock exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with prostate neoplasms.

What phase is Glucocorticoid in?

Glucocorticoid is in Phase 1 of clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of prostate neoplasms, and its clinical trial has been completed.

What clinical trials is Glucocorticoid in?

Glucocorticoid has been studied in one clinical trial with the identifier NCT01664728. This was an expanded access study of abiraterone acetate in patients with advanced prostate cancer who had completed clinical study COU-AA-001. The trial was conducted in the United Kingdom and enrolled 54 male participants aged 18 years and older.

Is Glucocorticoid the same as abiraterone acetate?

Glucocorticoid is not the same as abiraterone acetate. The clinical trial NCT01664728 was an expanded access study of abiraterone acetate, and Glucocorticoid is the drug being investigated in that study. The trial evaluated the drug in patients with advanced prostate cancer.