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Hormone Therapy

ORIC-101 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Oric Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
one post-treatment tumor biopsy during Cycle 2
Must have been on treatment with enzalutamide for at least 3 months prior to documented evidence of PSA progression defined as per PCWG3: minimum of 2 rising values (3 measurements) 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new medication to see if it is safe and effective when used with a common prostate cancer drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You need to have a biopsy of your tumor after completing the second cycle of treatment.
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You must have taken enzalutamide for at least 3 months before your PSA level showed signs of increasing. This increase should be confirmed by at least 2 rising values obtained a week apart, with the latest result being at least 2.0 ng/mL (or 1.0 ng/mL if PSA rise is the only sign of progression).
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You are expected to live for at least 3 more months.
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You have been diagnosed with a specific type of prostate cancer called adenocarcinoma.
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You are currently taking enzalutamide for metastatic prostate cancer and your testosterone level is below 50 ng/dL.
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Your platelet count is at least 100,000 per microliter.
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You have not had a tumor biopsy while taking enzalutamide before joining this study.
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You are in good physical condition and can perform daily activities without any major issues.
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You have a white blood cell count of at least 1500 cells per cubic millimeter.
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You may need to have a tumor biopsy at the end of treatment, but it's not required.

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
Number of Participants with Abnormal 12-lead ECG
Number of Participants with Abnormal Laboratory Values
Number of Participants with Abnormal Vital Signs
+4 more
Secondary outcome measures
Area under the curve (AUC(0-24))
Circulating tumor cells (CTCs) conversion
Duration of response (DOR)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment2 Interventions
RP2D dose
Group II: Dose EscalationExperimental Treatment2 Interventions
ORIC-101 dosed orally, once per day in combination with enzalutamide (160 mg) of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORIC-101
2018
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Oric PharmaceuticalsLead Sponsor
3 Previous Clinical Trials
139 Total Patients Enrolled
ORIC PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
549 Total Patients Enrolled
Pratik S. Multani, MDStudy DirectorORIC Pharmaceuticals
3 Previous Clinical Trials
181 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~17 spots leftby Mar 2025