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TerminatedNCT02606123Updated Mar 1, 2018

Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1/2 interventional study of EPI-506 in Prostatic Neoplasms, Genital Neoplasms, Male and Genital Diseases, Male, sponsored by ESSA Pharmaceuticals. Terminated at 5 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by ESSA Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Why this study was terminated
At end of Phase 1 excessive high pill burden (18 capsules/day)
Phase
Phase 1/2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Prostatic Neoplasms
  • Genital Neoplasms, Male
  • Genital Diseases, Male
  • Prostatic Diseases

Keywords

  • Prostate Cancer
  • Metastatic castration-resistant prostate cancer
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

ESSA Pharmaceuticals is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adenocarcinoma of the Prostate
  • 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
  • (ECOG) score between 0-1
  • Asymptomatic or mildly symptomatic

Exclusion criteria

Exclusion Criteria:

  • Candidates for cytotoxic chemotherapy
  • Received more than one
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    EPI-506

    Part I: Ascending doses of EPI-506 administered orally to define the maximum tolerated dose.

    Drug: EPI-506

Interventions

  • DrugEPI-506

    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.

06

What researchers measure

Primary outcomes

  1. Part I: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events

    Time frame: 12 weeks

  2. Part II: Prostate-specific antigen (PSA) response rate

    Time frame: 12 weeks

Secondary outcomes

  1. Part I: Define the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)

    Time frame: 9 months

  2. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by plasma area under the plasma concentration-time curve (AUC)

    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.

  3. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by maximum concentration (Cmax)

    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.

  4. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by observed pre-dose plasma concentration during multiple dosing (Ctrough)

    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.

  5. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by time to reach Cmax (tmax)

    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.

  6. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by apparent terminal elimination half-life (t1/2)

    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.

  7. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

    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.

  8. Part I: Pharmacokinetics (PK) profile of EPI-506

    Assessed by apparent clearance after extravascular administration (CL/F)

    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.

  9. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by AUC

    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.

  10. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by Cmax

    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.

  11. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by Ctrough

    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.

  12. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by tmax

    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.

  13. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by t1/2

    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.

  14. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by Vz/F

    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.

  15. Part I: Pharmacokinetics (PK) profile of EPI-002

    Assessed by CL/F

    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.

  16. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by AUC

    Time frame: 6 days

  17. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by Cmax

    Time frame: 6 days

  18. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by Ctrough

    Time frame: 6 days

  19. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by tmax

    Time frame: 6 days

  20. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by t1/2

    Time frame: 6 days

  21. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by Vz/F

    Time frame: 6 days

  22. Part I: Food effect on PK

    Following a single-dose of EPI-506 on Days 1 and 4 assessed by CL/F

    Time frame: 6 days

  23. Part I: PSA

    Evaluated as a Pharmacodynamic (PD) marker of response

    Time frame: Baseline to Week 12

  24. Part II: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events

    Time frame: 12 months

  25. Part II: To evaluate the PK of EPI-506

    Assessed by AUC

    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.

  26. Part II: To evaluate the PK of EPI-506

    Assessed by Cmax

    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.

  27. Part II: To evaluate the PK of EPI-506

    Assessed by Ctrough

    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.

  28. Part II: To evaluate the PK of EPI-506

    Assessed by tmax

    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.

  29. Part II: To evaluate the PK of EPI-506

    Assessed by t1/2

    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.

  30. Part II: To evaluate the PK of EPI-506

    Assessed by Vz/F

    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.

  31. Part II: To evaluate the PK of EPI-506

    Assessed by CL/F

    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.

  32. Part II: To evaluate the PK of EPI-002

    Assessed by AUC

    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.

  33. Part II: To evaluate the PK of EPI-002

    Assessed by Cmax

    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.

  34. Part II: To evaluate the PK of EPI-002

    Assessed by Ctrough

    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.

  35. Part II: To evaluate the PK of EPI-002

    Assessed by tmax

    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.

  36. Part II: To evaluate the PK of EPI-002

    Assessed by t1/2

    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.

  37. Part II: To evaluate the PK of EPI-002

    Assessed by Vz/F

    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.

  38. Part II: To evaluate the PK of EPI-002

    Assessed by CL/F

    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.

  39. Part II: Time to PSA progression

    Time frame: 12 months

  40. Part II: Radiographic progression

    Radiographic progression evaluated per modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1

    Time frame: 12 weeks

  41. Part II: Objective response

    Radiographic progression evaluation per mRECIST v1.1 in patients with measurable soft tissue disease at baseline

    Time frame: 12 weeks

Other outcomes

  1. Exploratory Objective: Biomarkers

    Circulating tumor cells (CTCs) with emphasis on androgen receptor splice variants (AR-V7)

    Time frame: 12-24 months

  2. Exploratory Objective: Pain assessments

    Assessed by Brief Pain Inventory-Short Form (BPI-SF) instrument

    Time frame: 12-24 months

07

Study locations

5 sites
  • Scottsdale Healthcare Hospitals DBA HonorHealth
    Scottsdale, Arizona 85258, United States
  • University of Michigan Health System
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • British Columbia Cancer Agency - Vancouver Centre
    Vancouver, British Columbia V5Z 4E6, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2015
First posted
Nov 17, 2015
Start
Oct 2015
Primary completionActual
Dec 2017
CompletionActual
Dec 2017
Last update
Mar 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02606123
Lead sponsor
ESSA Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 17, 2015
Start date
Oct 2015
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Mar 1, 2018

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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