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ORIC-944 for Metastatic Prostate Cancer
Study Summary
This trial is testing a new drug to treat prostate cancer that has spread. They are testing to see what dose is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have prostate cancer that has spread, including types like NEPC.I have not had severe heart issues or a heart attack in the last 6 months.I have Hepatitis B or C but it is well controlled.I am fully active or restricted in physically strenuous activity but can do light work.I have had brain metastases, but they are now stable after treatment.I do not have active gut diseases affecting medication absorption.I have prostate cancer and it got worse after treatment with specific hormone therapies but I've had no more than 2 chemotherapy treatments.I have had surgery to remove both testicles or am willing to continue treatment to keep my testosterone low.My cancer is getting worse, shown by higher PSA levels or new bone/soft tissue issues.I agree to and can undergo skin and tumor biopsies for the study.I have symptoms of HIV.My organs are working well.
- Group 1: Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current enrollment quota for this trial?
"For this research effort, 42 individuals who meet the pre-defined criteria are needed. Qualified patients may enroll in the trial from either Memorial Sloane Kettering Cancer Center located in New york City or Keystone Urology Specialists based out of Lancaster, Pennsylvania."
Are there any opportunities left to participate in this investigational research?
"Indeed, the clinicaltrials.gov website advertises that this medical study is presently enrolling participants. Initially posted on June 1st 2022, it was recently modified on September 19th 2022 and requires 42 patients to be recruited from 3 separate sites."
Has ORIC-944 been sanctioned by the FDA for medicinal use?
"ORIC-944's safety is currently an unconfirmed variable, so it was scored a 1. This estimation follows the typical protocols of Phase 1 clinical trials, where limited data exists regarding efficacy and safety."
What is the ultimate goal of this clinical experiment?
"Over the course of 12 months, primary outcomes of this clinical trial will be evaluated by measuring Time to maximum observed concentration (Tmax). Secondary objectives include gauging Clinical benefit rate (CBR) with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, estimating Duration of response (DOR), and assessing Progression-free survival (PFS), each taking into account RECIST v 1.1 standards."
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