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ORIC-944 for Metastatic Prostate Cancer
Phase 1
Recruiting
Research Sponsored by ORIC Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with metastatic prostate cancer, including those with neuroendocrine prostate cancer (NEPC) and/or small cell features
ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
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.
Who is the study for?
This trial is for men with metastatic prostate cancer who've had a bilateral orchiectomy or are on GnRH analogues. They must have progressed after treatment with certain androgen receptor antagonists and can't have had more than two chemo treatments in the mCRPC setting. Participants need to show disease progression, be able to undergo biopsies, have an ECOG status of 0 or 1, and adequate organ function.Check my eligibility
What is being tested?
The study aims to determine the optimal dose of ORIC-944 that patients can tolerate and its preliminary effectiveness against metastatic prostate cancer. It includes those with neuroendocrine features who've progressed despite previous therapies.See study design
What are the potential side effects?
While specific side effects of ORIC-944 aren't listed here, common ones for similar drugs include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, hormonal imbalances, liver issues, and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prostate cancer that has spread, including types like NEPC.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had surgery to remove both testicles or am willing to continue treatment to keep my testosterone low.
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My cancer is getting worse, shown by higher PSA levels or new bone/soft tissue issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent plasma terminal elimination half-life (t1/2)
Area under the curve (AUC)
Maximum plasma concentration (Cmax)
+2 moreSecondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Objective response rate (ORR)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
Find a Location
Who is running the clinical trial?
ORIC PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
667 Total Patients Enrolled
Pratik S. Multani, MDStudy DirectorORIC Pharmaceuticals
3 Previous Clinical Trials
229 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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