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Corticosteroid

CORT125281 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
M0 disease is allowed
Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures, and provide written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
AUC 0-24hr PK parameter
AUC 0-infinity PK parameter
AUC 0-last Pharmacokinetic (PK) parameter
+17 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Expansion - Abi-Resistant Cohort Food EffectExperimental Treatment2 Interventions
Sub-Cohort (first 10 patients enrolled into Cohort A). Patients enrolled into this subcohort will receive a single dose of CORT125281 at Cycle 1 Day -7 and a single dose of CORT125281 at Cycle 1 Day 1 30 minutes after a standard breakfast to assess the effect of food on PK parameters. Patients will then begin CORT125281 in combination with enzalutamide on Cycle 1 Day 2 and continue in 28-day dosing cycles.
Group II: Dose Expansion - Abi-Resistant CohortExperimental Treatment2 Interventions
Patients who have progressed during treatment with abiraterone and no other AR-blocking therapies will be treated with CORT125281 and enzalutamide.
Group III: Dose Expansion - ARant-Resistant CohortExperimental Treatment2 Interventions
Patients who progressed during treatment with enzalutamide or second-generation AR-blocking therapies will be treated with a daily dose of CORT125281 and enzalutamide.
Group IV: Dose Determination Segment 2 (Double-Blind) - Arm BExperimental Treatment3 Interventions
Patients randomized to this cohort will receive enzalutamide, placebo, and CORT125281.
Group V: Dose Determination Segment 2 (Double-Blind) - Arm AExperimental Treatment2 Interventions
Patients randomized to this cohort will receive enzalutamide and a titrated dose of CORT125281. Enzalutamide will be continued at the dose currently tolerated by the patient at screening.
Group VI: Dose Determination Segment 1Experimental Treatment2 Interventions
Patients will be treated with enzalutamide monotherapy once daily for 28 days followed by combination treatment with CORT125281 at escalating dose levels and enzalutamide once daily in 28-day dosing cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CORT125281
2017
Completed Phase 2
~40
Enzalutamide (Xtandi)
2017
Completed Phase 2
~80
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,341 Total Patients Enrolled
2 Trials studying Prostate Cancer
61 Patients Enrolled for Prostate Cancer
Andreas Grauer, MDStudy DirectorCorcept Therapeutics
2 Previous Clinical Trials
91 Total Patients Enrolled
William Guyer, PharmDStudy DirectorCorcept Therapeutics
1 Previous Clinical Trials
43 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any previous investigations featuring CORT125281?

"In 2005, the first CORT125281 trial was conducted at Rosemere Cancer Centre in Royal Preston Hospital. Since then, 18402 trials have been completed and 98 are still undergoing clinical testing; many of which occur within Madison, Wisconsin's medical community."

Answered by AI

Is this clinical investigation taking place in multiple Canadian healthcare facilities?

"The investigation is currently enrolling patients from 5 different locations, including Madison, Scottsdale and Detroit. It might be beneficial to select the most proximal site in order to reduce travel demands if you decide to partake."

Answered by AI

What is the estimated recruitment for this trial?

"Affirmative. According to clinicaltrials.gov, this investigation is actively recruiting participants as of November 1st 2021. It was first listed on December 15th 2017 and requires 80 volunteers from 5 different sites."

Answered by AI

Are any positions still available for participants in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this trial is actively recruiting patients, with an initial post date of December 15th 2017 and a recent update on November 1st 2021. 80 individuals need to be enrolled from 5 different medical facilities."

Answered by AI
~5 spots leftby Mar 2025