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Oral EPI-7386 in Patients With 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 1, 2022
Sponsor:
Information provided by (Responsible Party):
ESSA Pharmaceuticals

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.

The study will be conducted in 2 parts:

  • Part 1a: To evaluate the safety and tolerability of EPI-7386
  • Part 1b: To evaluate 2 cohorts (Cohort A and Cohort B) enrolling in parallel

    • Part 1b Cohort A: Will further evaluate the safety and tolerability of EPI-7386 in a patient population that has not been previously treated with chemotherapy.
    • Part 1b Cohort B: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (up to 12 weeks prior to the start of standard of care therapy) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 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 Castration-Resistant Prostate Cancer
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Experimental: Cohort 7
1200 mg EPI-7386
Drug: EPI-7386 (BID)
Twice daily oral dose of EPI-7386




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: 2 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 Cohort A is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% and ≥90% at any time point during daily dosing with EPI-7386. [ Time Frame: 5 months ]
  3. The primary efficacy variable for Part 1b Cohort B is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% and ≥90% at any time point during daily dosing with EPI-7386 up to Week 12. [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Part 1a 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.
  • Limited further treatment options available known to confer clinical benefit in this disease setting from the perspective of the treating physician. Specifically, patients must have progressed on at least 2, but not more than 3, prior approved systemic therapies for mCRPC which include at least one, but not more than 2, second generation anti-androgen drug.
  • Patients may have received prior docetaxel for mCSPC or mCRPC but must not have had disease progression during, or within 6 months of completing chemotherapy. Only one line of prior chemotherapy is allowed.
  • 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.

Part 1b Cohort A Inclusion Criteria:

The inclusion criteria for this cohort are the same as for Part 1a with the exception of: prior chemotherapy is not allowed for this cohort of patients.

Part 1b Cohort B 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).
  • Patients who received a first generation anti-androgen as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease (PSA) progression off the anti-androgen for at least 4 weeks prior to enrollment.
  • At least 4 weeks must have elapsed from the use of 5-α reductase inhibitors, estrogens, and any other anti-cancer therapy prior to enrollment.
  • At least 4 weeks must have elapsed from major surgery or radiation therapy prior to enrollment.
  • The patient must have recovered from toxicities related to any prior treatments.
  • Castrate at screening.
  • Demonstrate adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

Part 1a and Part 1b Cohort A 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.
  • Any lutamides or abiraterone within 14 days or 5 half-lives, whichever is longer prior to start 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.
  • Received prior chemotherapy (for Part 1b Cohort A only).
  • 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 strong inducers of CYP3A within 14 days of the first dose of study drug.

Part 1b Cohort B Exclusion Criteria:

  • Presence of distant metastases, including visceral, nodal and bones involvement. Exception: pelvic lymph nodes < 2 cm in short axis (N1) located below the iliac bifurcation are allowed.
  • Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis due to primary tumor.
  • Prior treatment with second generation anti-androgens.
  • Prior treatment with CYP17 inhibitors.
  • Prior treatment with radiopharmaceutical agents, immunotherapy, or any other investigational agent for nmCRPC.
  • Prior chemotherapy.
  • History or evidence of: prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 3 years prior to enrollment; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events; uncontrolled hypertension.
  • Gastrointestinal disorder affecting absorption.
  • Use of strong inducers of CYP3A within 14 days of the first dose of study drug.

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 Completed
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
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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 1, 2022
Last Verified: August 2022

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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