Prostate CancerPhase 1NCT04677855
Study of PCUR-101 in Combination With ADT in Patients With mCRPC
A Phase 1 study testing PCUR-101, Dutasteride 0.5 mg and Abiraterone and Prednisone in people with Prostate Cancer, run by Pellficure Pharmaceuticals, Inc at 4 sites in 2 countries.
Trial summary
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PCUR-101, Dutasteride 0.5 mg and Abiraterone and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Mar 2021to 20 Nov 2023
- Phase
- Phase 1
- 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
- Histologically confirmed diagnosis of prostate cancer
- Demonstrates metastatic CRPC
- Castrate level of serum testosterone at screening
- Adequate hematologic, renal, and hepatic function
- ECOG status ≤1
- Life expectancy of at least 3 months
- No more than one prior course of cytotoxic chemotherapy
Who cannot join
- Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- Visceral metastasis excluding lymph nodes
- Use of opiate analgesics for prostate cancer pain or non-cancer pain
- other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks
- History of bleeding disorder
- History of seizure disorder
Show all 11Show fewer
- Concomitant use of warfarin
- Prior exposure to PCUR-101
- History of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia
- Received wide-field external beam radiation therapy within 4 weeks
- Moderate to severe neuropathy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Nebraska Cancer Specialist
Omaha, Nebraska, 68130
Australia2 sites
Southern Oncology Clinical Research
Bedford Park, South Australia, 5042
St. George Private Hospital
Kogarah, New South Wales, 2217
About this study
Official title: A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.
Read the detailed description
Dose Escalation Phase: Eligible patients will enter the study and start receiving daily doses of PCUR-101 during Cycle 1. Subsequent dose cohorts will receive the next higher dose of PCUR-101 according to a 3 + 3 design until the MTD is determined. Patients may remain on these treatment cycles if they do not progress or experience any dose limiting toxicities (DLTs).
Dose Expansion Phase: Once the MTD has been determined, approximately 18 patients in 3 cohorts will be enrolled for further evaluations of safety, PK, and preliminary clinical activity during successive 28-day cycles in the dose expansion phase: Expansion Cohort 1 will receive PCUR-101 at the MTD, Expansion Cohort 2 will receive PCUR-101 at one dose level lower than the MTD and dutasteride once daily, and Expansion Cohort 3 (6 patients) will receive PCUR-101 at one dose level lower than the MTD in patients about to start abiraterone (1000 mg QD) and prednisone (5 mg twice daily [BID]) as their standard of care.
- Conditions
- Prostate Cancer
- Being tested
- PCUR-101, Dutasteride 0.5 mg, Abiraterone and Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCUR-101Drug
50 mg capsules
Dutasteride 0.5 mgDrug
0.5 mg capsules
Abiraterone and PrednisoneDrug
500 mg tablets Abiraterone with 5 mg Prednisone Tablets
| Study group | Role | What they receive |
|---|---|---|
| PCUR-101 Dose Escalation | Experimental | PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase Receives: Drug: PCUR-101 |
| PCUR-101 Dose Expansion Cohort 1 | Experimental | PCUR-101 dosed orally once per day in 28 day cycles Receives: Drug: PCUR-101 |
| PCUR-101 Dose Expansion Cohort 2 | Experimental | PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles Receives: Drug: PCUR-101; Drug: Dutasteride 0.5 mg |
| PCUR-101 Dose Expansion Cohort 3 | Experimental | PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles Receives: Drug: PCUR-101; Drug: Abiraterone and Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicity
Incidence of Adverse Adverse Events
Measured: over the first 28 days of dosing
Secondary outcomes (5)
Determination of pharmacokinetic parameters - Tmax
time to peak concentrations of PCUR-101
Measured: over the first 28 days of dosing
Determination of pharmacokinetic parameters - Cmax
peak concentrations of PCUR-101
Measured: over the first 28 days of dosing
Determination of pharmacokinetic parameters - T1/2
time from maximum concentration PCUR-101 to a reduction of plasma concentration by 50%
Measured: over the first 28 days of dosing
Preliminary Evidence of efficacy/anti tumor activity - PSA levels
as assessed by PSA changes
Measured: through study completion, average of 12 months
Preliminary Evidence of efficacy/anti tumor activity - RECIST
as assessed by RECIST 1.1 criteria
Measured: through study completion, average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start30 Mar 2021
- Primary completion23 Oct 2023
- Study completion20 Nov 2023
Why it stopped: Business Decision due to insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1 dose escalation followed by a dose expansion
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pellficure Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677855
- Sponsor's protocol ID
- PCUR101-003
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04677855
- Acronym / sponsor ID
- PCUR101-003
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision due to insufficient enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pellficure Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 21 Dec 2020 (actual)
- 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.
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.
Detailed description
Dose Escalation Phase: Eligible patients will enter the study and start receiving daily doses of PCUR-101 during Cycle 1. Subsequent dose cohorts will receive the next higher dose of PCUR-101 according to a 3 + 3 design until the MTD is determined. Patients may remain on these treatment cycles if they do not progress or experience any dose limiting toxicities (DLTs).
Dose Expansion Phase: Once the MTD has been determined, approximately 18 patients in 3 cohorts will be enrolled for further evaluations of safety, PK, and preliminary clinical activity during successive 28-day cycles in the dose expansion phase: Expansion Cohort 1 will receive PCUR-101 at the MTD, Expansion Cohort 2 will receive PCUR-101 at one dose level lower than the MTD and dutasteride once daily, and Expansion Cohort 3 (6 patients) will receive PCUR-101 at one dose level lower than the MTD in patients about to start abiraterone (1000 mg QD) and prednisone (5 mg twice daily [BID]) as their standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Part 1 dose escalation followed by a dose expansion
| Arm | Type | Receives |
|---|---|---|
| PCUR-101 Dose Escalation | Experimental | Drug: PCUR-101PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase |
| PCUR-101 Dose Expansion Cohort 1 | Experimental | Drug: PCUR-101PCUR-101 dosed orally once per day in 28 day cycles |
| PCUR-101 Dose Expansion Cohort 2 | Experimental | Drug: PCUR-101, Drug: Dutasteride 0.5 mgPCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles |
| PCUR-101 Dose Expansion Cohort 3 | Experimental | Drug: PCUR-101, Drug: Abiraterone and PrednisonePCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles |
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)
- Histologically confirmed diagnosis of prostate cancer
- Demonstrates metastatic CRPC
- Castrate level of serum testosterone at screening
- Adequate hematologic, renal, and hepatic function
- ECOG status ≤1
Key exclusion criteria (11 listed)
- Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- Visceral metastasis excluding lymph nodes
- Use of opiate analgesics for prostate cancer pain or non-cancer pain
- other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks
- History of bleeding disorder
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 |
|---|---|---|
| PCUR-10150 mg capsules | Drug | PCUR-101 Dose Escalation, PCUR-101 Dose Expansion Cohort 1, PCUR-101 Dose Expansion Cohort 2, PCUR-101 Dose Expansion Cohort 3 |
| Dutasteride 0.5 mg0.5 mg capsules | Drug | PCUR-101 Dose Expansion Cohort 2 |
| Abiraterone and Prednisone500 mg tablets Abiraterone with 5 mg Prednisone Tablets | Drug | PCUR-101 Dose Expansion Cohort 3 |
Primary outcome
Occurrence of Dose Limiting Toxicity
Time frame: over the first 28 days of dosing
Incidence of Adverse Adverse Events
5 secondary outcomes
Determination of pharmacokinetic parameters - Tmax
Time frame: over the first 28 days of dosing
Determination of pharmacokinetic parameters - Cmax
Time frame: over the first 28 days of dosing
Determination of pharmacokinetic parameters - T1/2
Time frame: over the first 28 days of dosing
Preliminary Evidence of efficacy/anti tumor activity - PSA levels
Time frame: through study completion, average of 12 months
Preliminary Evidence of efficacy/anti tumor activity - RECIST
Time frame: through study completion, average of 12 months
Results and safety
The study was stopped early (reason given: Business Decision due to insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PCUR-101, Dutasteride 0.5 mg and Abiraterone and Prednisone in people with Prostate Cancer, run by Pellficure Pharmaceuticals, Inc at 4 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 11 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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 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.
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: Business Decision due to insufficient enrollment). 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?
Occurrence of Dose Limiting Toxicity (time frame: over the first 28 days of dosing). 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 10 Apr 2024.