Metastatic Castration-Resistant Prostate CancerPhase 1NCT03137758
A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing PCUR - 101 in people with Metastatic Castration-Resistant Prostate Cancer, run by Pellficure Pharmaceuticals, Inc at 3 sites in United States.
Trial summary
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- PCUR - 101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jul 2017to 17 Sep 2019
- 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 metastatic CRPC
- standard of care androgen deprivation treatment
- castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
- progressive disease while receiving androgen deprivation therapy
- previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
- adequate hematologic, renal and hepatic function
- KPS of ≥ 70 or ECOG of 0 to 1
Who cannot join
- pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- use of opiate analgesics for prostate cancer pain within 4 week of treatment start
- more than one sequential second generation AR-directed therapy
- received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
- history of bleeding disorder
- history of seizure disorder
Show all 10Show fewer
- concomitant use of therapeutic anticoagulation
- history of or current cardiac issues
- received external beam radiation therapy within 4 weeks
- CTCAE Grade > 2 neuropathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC
- Being tested
- PCUR - 101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCUR - 101Drug
PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Level 1 (50 mg) PCUR-101 | Experimental | Starting Dose, 3+3 Cohort Design Receives: Drug: PCUR - 101 |
| Level 2 (100 mg) PCUR-101 | Experimental | Not described Receives: Drug: PCUR - 101 |
| Level 3 (150 mg) PCUR-101 | Experimental | Not described Receives: Drug: PCUR - 101 |
| Level 4 (200 mg) PCUR-101 | Experimental | Not described Receives: Drug: PCUR - 101 |
| Level 5 (250 mg) PCUR-101 | Experimental | Not described Receives: Drug: PCUR - 101 |
| Level 6 (300 mg) PCUR-101 | Experimental | Not described Receives: Drug: PCUR - 101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities and Adverse Events
determined by type and severity using the most recent version of the CTCAE criteria
Measured: 28 days
Secondary outcomes (2)
Response
a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria
Measured: up to 2 years
Toxicities and adverse events
determined by type and severity using the most recent version of the CTCAE criteria
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start24 Jul 2017
- Primary completion3 Apr 2019
- Study completion17 Sep 2019
Why it stopped: Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant 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
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03137758
- Sponsor's protocol ID
- PCUR101-001
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2017
- Last updated
- 9 Mar 2020
- 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 9 Mar 2020. 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 Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03137758
- Acronym / sponsor ID
- PCUR101-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pellficure Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 3 May 2017 (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 of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Level 1 (50 mg) PCUR-101 | Experimental | Drug: PCUR - 101Starting Dose, 3+3 Cohort Design |
| Level 2 (100 mg) PCUR-101 | Experimental | Drug: PCUR - 101 |
| Level 3 (150 mg) PCUR-101 | Experimental | Drug: PCUR - 101 |
| Level 4 (200 mg) PCUR-101 | Experimental | Drug: PCUR - 101 |
| Level 5 (250 mg) PCUR-101 | Experimental | Drug: PCUR - 101 |
| Level 6 (300 mg) PCUR-101 | Experimental | Drug: PCUR - 101 |
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 metastatic CRPC
- standard of care androgen deprivation treatment
- castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
- progressive disease while receiving androgen deprivation therapy
- previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
Key exclusion criteria (10 listed)
- pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- use of opiate analgesics for prostate cancer pain within 4 week of treatment start
- more than one sequential second generation AR-directed therapy
- received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents 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 - 101PCUR-101 Capsules 25 mg are solid dosage forms for oral administration | Drug | Level 1 (50 mg) PCUR-101, Level 2 (100 mg) PCUR-101, Level 3 (150 mg) PCUR-101, Level 4 (200 mg) PCUR-101, Level 5 (250 mg) PCUR-101, Level 6 (300 mg) PCUR-101 |
Primary outcome
Toxicities and Adverse Events
Time frame: 28 days
determined by type and severity using the most recent version of the CTCAE criteria
2 secondary outcomes
Response
Time frame: up to 2 years
Toxicities and adverse events
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PCUR - 101 in people with Metastatic Castration-Resistant Prostate Cancer, run by Pellficure Pharmaceuticals, Inc at 3 sites in United States.
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 10 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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: Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.). 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?
Toxicities and Adverse Events (time frame: 28 days). 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 9 Mar 2020.