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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05075577




Registration number
NCT05075577
Ethics application status
Date submitted
14/09/2021
Date registered
13/10/2021
Date last updated
28/08/2024

Titles & IDs
Public title
EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With mCRPC
Scientific title
A Phase 1/2 Study of EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
EPI-7386-CS-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide
Treatment: Drugs - EPI-7386 with Enzalutamide

Experimental: Phase 1 Cohort 1 - 600 mg QD EPI-7386 in combination of Enzalutamide120 mg

Experimental: Phase 1 Cohort 2 - 800 mg QD EPI-7386 in combination of Enzalutamide120 mg

Experimental: Phase 1 Cohort 3 - 600 mg BID EPI-7386 in combination of Enzalutamide120 mg

Experimental: Phase 1 Cohort 4 - RP2D mg EPI-7386 in combination of Enzalutamide160 mg

Experimental: Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1) - RP2D mg EPI-7386 in combination of Enzalutamide RP2D mg

Active comparator: Phase 2 Enzalutamide single agent - Enzalutamide 160 mg


Treatment: Drugs: Enzalutamide
Daily oral dose of enzalutamide

Treatment: Drugs: EPI-7386 with Enzalutamide
Daily oral dose of EPI-7386 in combination of enzalutamide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Incidence of Dose Limiting Toxicities
Timepoint [1] 0 0
Baseline to End of Cycle 1 (each cycle is 28 days)
Primary outcome [2] 0 0
Phase 1: Incidence of treatment emergent adverse events
Timepoint [2] 0 0
Baseline to 30 days after last dose of study drug
Primary outcome [3] 0 0
Phase 1: Incidence of laboratory abnormalities as a measure of safety and tolerability of EPI-7386
Timepoint [3] 0 0
Baseline to 30 days after last dose of study drug
Primary outcome [4] 0 0
Phase 1: Changes in ECOG performance status
Timepoint [4] 0 0
Baseline to 30 days after last dose of study drug
Primary outcome [5] 0 0
Phase 2: Proportion of subjects with a prostate-specific antigen decline of >50% (PSA50) at Week 12
Timepoint [5] 0 0
Baseline to Week 12

Eligibility
Key inclusion criteria
* Males =18 years.
* Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma.
* 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.
* Naïve to second generation anti-androgens.
* Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Ongoing ADT with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy or history of bilateral orchiectomy, with castrate level testosterone.
* Serum testosterone =1.73 nmol/L (50 ng/dL).
* Subjects receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 28 days prior to the start of study treatment.
* Demonstrate adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Biologic anti-cancer therapy within 28 days prior to the start of study treatment.
* Use of hormonal agents with anti-tumor activity against prostate cancer within 28 days prior to the start of study treatment.
* Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity within 28 days prior to the start of study treatment or plans to initiate during the study.
* Intervention with any chemotherapy, investigational agents, or other anti-cancer drugs within 28 days of the first dose of study treatment.
* Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study treatment.
* Received limited-field palliative bone radiotherapy >5 fractions and/or any radiotherapy within 2 weeks prior to the start of study treatment.
* Received a blood transfusion within 28 days of hematologic screening labs.
* Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 28 days before signing of informed consent.
* Spinal cord compression.
* Diagnosis of another clinically significant malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or non-invasive malignancies.
* Gastrointestinal issues affecting absorption.
* Significant cardiovascular disease.
* Known history of seizure or conditions that may pre-dispose them to seizure, including brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, and brain arteriovenous malformation.
* Concurrent disease or any clinically significant abnormality.
* Known or suspected hypersensitivity to any components of the formulation used for EPI-7386 or enzalutamide.
* Use of strong inhibitors of CYP2C8.
* Use of strong inducers of CYP3A.
* Use of narrow therapeutic index sensitive CYP2C8 or sensitive substrates for CYP3A and CYP2B6.
* Use of granulocyte colony stimulating factor within 7 days prior to screening laboratories.
* Not a candidate for enzalutamide treatment.
* Patients with rare hereditary problems of fructose intolerance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Eastern Health - Box Hill
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ESSA Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Karen Villaluna
Address 0 0
Country 0 0
Phone 0 0
6504498423
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05075577