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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
Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone
Evidence of progressive disease by PCWG3 criteria for study entry: - Rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart with the latest result being at least 2.0 ng/mL (or 1.0 ng/mL if PSA rise is the only indication of progression) - Confirmation of 2 new bone lesions on last systemic therapy - Soft tissue progression per RECIST 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

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 below
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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.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Apparent plasma terminal elimination half-life (t1/2)
Area under the curve (AUC)
Maximum plasma concentration (Cmax)
+2 more
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Objective response rate (ORR)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
597 Total Patients Enrolled
Pratik S. Multani, MDStudy DirectorORIC Pharmaceuticals
3 Previous Clinical Trials
229 Total Patients Enrolled

Media Library

ORIC-944 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05413421 — Phase 1
Prostate Cancer Research Study Groups: Dose Escalation
Prostate Cancer Clinical Trial 2023: ORIC-944 Highlights & Side Effects. Trial Name: NCT05413421 — Phase 1
ORIC-944 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05413421 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~16 spots leftby Feb 2025