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Oral EPI-7386 in Patients With Metastatic Castration-Resistant Prostate Cancer (EPI-7386)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421222
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
ESSA Pharmaceuticals

Study Description
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Brief Summary:

This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386.

Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects.

There are other important things that will be evaluated during the study:

  • How the amount of EPI-7386 in the blood changes over time.
  • The effect of EPI-7386 on prostate cancer.
  • The effect of EPI-7386 on certain substances in the body.
  • The possibility that EPI-7386 can interact with other drugs.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: EPI-7386 (QD) Drug: EPI-7386 (BID) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
200 mg EPI-7386
 Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386
Experimental: Cohort 2
400 mg EPI-7386
 Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386
Experimental: Cohort 3
600 mg EPI-7386
 Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386
Experimental: Cohort 4
800 mg EPI-7386
 Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386
Experimental: Cohort 5
1000 mg EPI-7386
 Drug: EPI-7386 (QD)
Once daily oral dose of EPI-7386
Experimental: Cohort 6
800 mg EPI-7386
 Drug: EPI-7386 (BID)
Twice daily oral dose of EPI-7386


Outcome Measures
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Primary Outcome Measures :
  1. The primary safety variable for Part 1a of the study is the incidence of protocol-defined DLT during the DLT assessment period (first 28 days of dosing). [ Time Frame: 5 months ]
    The DLTs will be characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE version 5.0]), timing, seriousness, and relationship to study drug.

  2. The primary efficacy variable for Part 1b of the study is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% at any time point during daily dosing with EPI-7386. [ Time Frame: 5 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male 18 years of age or older.
  • Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
  • Evidence of castration-resistant prostate cancer (CRPC).
  • Presence of metastatic disease at study entry documented by 1 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
  • No further treatment options available known to confer clinical benefit in this disease setting from the perspective of the treating physician (maximum 3 prior approved systemic therapies for mCRPC).
  • Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
  • The patient must have recovered from toxicities related to any prior treatments.
  • Castrate at screening.
  • Patients receiving bisphosphonates or other approved bone-targeting therapy must be on a stable dose for at least 4 weeks prior to the start of study drug.
  • Demonstrate adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

Exclusion Criteria:

  • Biologic anti-cancer therapy or a cytotoxic chemotherapy within 4 weeks prior to the start of study drug.
  • Use of hormonal agents with anti-tumor activity against prostate cancer within 4 weeks prior to the start of study drug.
  • Intervention with any chemotherapy, investigational agents, or other anti-cancer drugs within 14 days or 5 half-lives, whichever is longer, of the first dose of study drug.
  • Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study drug.
  • Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study drug.
  • Received a blood transfusion within 28 days of screening.
  • Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 4 weeks before enrollment.
  • Spinal cord compression.
  • Diagnosis of another invasive malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma.
  • Gastrointestinal disorder affecting absorption.
  • Significant cardiovascular disease.
  • Concurrent disease or any clinically significant abnormality.
  • Use of compounds known to be strong inducers and strong inhibitors of CYP3A and CYP2C8 within 14 days of the first dose of study drug.
  • Use of narrow therapeutic index sensitive CYP2C8 or sensitive substrates for CYP3A and CYP2B6.
  • Presence of metastasis to soft-tissue other than lymph nodes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421222


Contacts
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Contact: Karen Villaluna 650-449-8400 kvillaluna@essapharma.com

Locations
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United States, Florida
Hematology Oncology Associates of the Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Center of NV Las Vegas Recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Canada, British Columbia
BC Cancer Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
ESSA Pharmaceuticals
More Information
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Responsible Party: ESSA Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04421222    
Other Study ID Numbers: EPI-7386-CS-001
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases