Prostatic NeoplasmsPhase 1/2NCT02606123
Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 study testing EPI-506 in people with Prostatic Neoplasms and Genital Neoplasms, Male, run by ESSA Pharmaceuticals at 5 sites in 2 countries.
Trial summary
The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Genital Neoplasms, Male, Genital Diseases, Male
- What is being tested?
- EPI-506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2015to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of the Prostate
- Metastatic Disease with at least one lesion on bone scan and/or soft tissue on CT/MRI
- Demonstrated progression on abiraterone and/or enzalutamide
- Demonstrated PSA progression within 12 weeks of study participation
- Castrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapy
- Eastern Cooperative Oncology Group (ECOG) score between 0-1
- Asymptomatic or mildly symptomatic
Who cannot join
- Candidates for cytotoxic chemotherapy
- Received more than one line of chemotherapy
- Received more than one treatment course of enzalutamide or abiraterone
- Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa)
- Known intra-cerebral disease or brain mets
- Spinal cord compression within 6 months
- Prior treatment with investigative androgen receptor (AR) agents
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Karmanos Cancer Institute
Detroit, Michigan, 48201
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, 85258
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Canada1 site
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase 1/2 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-506 in Patients With Metastatic Castration-Resistant Prostate Cancer
The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II.
In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.
- Being tested
- EPI-506
- Keywords
- Prostate Cancer, Metastatic castration-resistant prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Genital Diseases, Male, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-506Drug
Patients will receive EPI-506 as an oral softgel capsule.
Part 1:
Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. During the Single-Dose Period, patients will first receive a dose of EPI-506 in the fasted state followed by 2 days of washout, and then patients will receive a second dose of EPI-506 in the fed state followed by 2 days of washout. Patients will then enter the Multiple Dosing and Long-term Dosing Period where they will receive once or twice daily dosing in a fed or fasted state until they meet discontinuation criteria.
Part 2:
The dose in Part 2 will be determined in Part 1 of the study. Patients will receive the Part 2 dose daily until they meet discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| EPI-506 | Experimental | Part I: Ascending doses of EPI-506 administered orally to define the maximum tolerated dose. Receives: Drug: EPI-506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
Measured: 12 weeks
Part II: Prostate-specific antigen (PSA) response rate
Measured: 12 weeks
Secondary outcomes (41)
Part I: Define the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Measured: 9 months
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by plasma area under the plasma concentration-time curve (AUC)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by maximum concentration (Cmax)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by observed pre-dose plasma concentration during multiple dosing (Ctrough)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by time to reach Cmax (tmax)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by apparent terminal elimination half-life (t1/2)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Assessed by apparent clearance after extravascular administration (CL/F)
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by AUC
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by Cmax
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by Ctrough
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by tmax
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by t1/2
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by Vz/F
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Assessed by CL/F
Measured: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by AUC
Measured: 6 days
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by Cmax
Measured: 6 days
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by Ctrough
Measured: 6 days
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by tmax
Measured: 6 days
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by t1/2
Measured: 6 days
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by Vz/F
Measured: 6 days
Part I: Food effect on PK
Following a single-dose of EPI-506 on Days 1 and 4 assessed by CL/F
Measured: 6 days
Part I: PSA
Evaluated as a Pharmacodynamic (PD) marker of response
Measured: Baseline to Week 12
Part II: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
Measured: 12 months
Part II: To evaluate the PK of EPI-506
Assessed by AUC
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Assessed by Cmax
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Assessed by Ctrough
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Assessed by tmax
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Assessed by t1/2
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Assessed by Vz/F
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Assessed by CL/F
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by AUC
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by Cmax
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by Ctrough
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by tmax
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by t1/2
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by Vz/F
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Assessed by CL/F
Measured: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: Time to PSA progression
Measured: 12 months
Part II: Radiographic progression
Radiographic progression evaluated per modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1
Measured: 12 weeks
Part II: Objective response
Radiographic progression evaluation per mRECIST v1.1 in patients with measurable soft tissue disease at baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: At end of Phase 1 excessive high pill burden (18 capsules/day)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESSA Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Perabo, MD, PhD, Study director, ESSA Pharmaceuticals Corp.Robert B. Montgomery, MD, Principal investigator, Seattle Cancer Care AllianceKim N. Chi, MD, Principal investigator, British Columbia Cancer Agency - Vancouver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606123
- Sponsor's protocol ID
- EPI-506-CS-0001
- Status last verified
- Feb 2018
- First submitted
- 22 Oct 2015
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-506 in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02606123
- Acronym / sponsor ID
- EPI-506-CS-0001
- Keywords
- Prostate Cancer, Metastatic castration-resistant prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At end of Phase 1 excessive high pill burden (18 capsules/day)
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ESSA PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II.
In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPI-506 | Experimental | Drug: EPI-506Part I: Ascending doses of EPI-506 administered orally to define the maximum tolerated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adenocarcinoma of the Prostate
- Metastatic Disease with at least one lesion on bone scan and/or soft tissue on CT/MRI
- Demonstrated progression on abiraterone and/or enzalutamide
- Demonstrated PSA progression within 12 weeks of study participation
- Castrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapy
Key exclusion criteria (7 listed)
- Candidates for cytotoxic chemotherapy
- Received more than one line of chemotherapy
- Received more than one treatment course of enzalutamide or abiraterone
- Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa)
- Known intra-cerebral disease or brain mets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-506Patients will receive EPI-506 as an oral softgel capsule. Part 1: Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. During the Single-Dose Period, patients will first receive a dose of EPI-506 in the fasted state followed by 2 days of washout, and then patients will receive a second dose of EPI-506 in the fed state followed by 2 days of washout. Patients will then enter the Multiple Dosing and Long-term Dosing Period where they will receive once or twice daily dosing in a fed or fasted state until they meet discontinuation criteria. Part 2: The dose in Part 2 will be determined in Part 1 of the study. Patients will receive the Part 2 dose daily until they meet discontinuation criteria. | Drug | EPI-506 |
Primary outcome
Part I: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
Time frame: 12 weeks
Part II: Prostate-specific antigen (PSA) response rate
Time frame: 12 weeks
41 secondary outcomes
Part I: Define the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Time frame: 9 months
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-506
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Pharmacokinetics (PK) profile of EPI-002
Time frame: Pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, 24h, and 48h after dose; Day 8 at pre-dose, and at 15min, 30min 1h, 2h, 4h, 6h, 8h, 12h, 24h after dose.
Part I: Food effect on PK
Time frame: 6 days
Part I: Food effect on PK
Time frame: 6 days
Part I: Food effect on PK
Time frame: 6 days
Part I: Food effect on PK
Time frame: 6 days
Part I: Food effect on PK
Time frame: 6 days
Part I: Food effect on PK
Time frame: 6 days
Part I: Food effect on PK
Time frame: 6 days
Part I: PSA
Time frame: Baseline to Week 12
Part II: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
Time frame: 12 months
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-506
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: To evaluate the PK of EPI-002
Time frame: Day 8 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, 8h, 12h, and 24h after dose; Week 12 at pre-dose, and at 15min, 30min, 1h, 2h, 4h, 6h, and 8h after dose.
Part II: Time to PSA progression
Time frame: 12 months
Part II: Radiographic progression
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: At end of Phase 1 excessive high pill burden (18 capsules/day)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Perabo, MD, PhD study director
ESSA Pharmaceuticals Corp.
Robert B. Montgomery, MD principal investigator
Seattle Cancer Care Alliance
Kim N. Chi, MD principal investigator
British Columbia Cancer Agency - Vancouver Centre
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EPI-506 in people with Prostatic Neoplasms and Genital Neoplasms, Male, run by ESSA Pharmaceuticals at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At end of Phase 1 excessive high pill burden (18 capsules/day)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part I: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.