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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04677855




Registration number
NCT04677855
Ethics application status
Date submitted
14/12/2020
Date registered
21/12/2020
Date last updated
10/04/2024

Titles & IDs
Public title
Study of PCUR-101 in Combination With ADT in Patients With mCRPC
Scientific 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
Secondary ID [1] 0 0
PCUR101-003
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 - PCUR-101
Treatment: Drugs - Dutasteride 0.5 mg
Treatment: Drugs - Abiraterone and Prednisone

Experimental: PCUR-101 Dose Escalation - PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase

Experimental: PCUR-101 Dose Expansion Cohort 1 - PCUR-101 dosed orally once per day in 28 day cycles

Experimental: PCUR-101 Dose Expansion Cohort 2 - PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles

Experimental: PCUR-101 Dose Expansion Cohort 3 - PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles


Treatment: Drugs: PCUR-101
50 mg capsules

Treatment: Drugs: Dutasteride 0.5 mg
0.5 mg capsules

Treatment: Drugs: Abiraterone and Prednisone
500 mg tablets Abiraterone with 5 mg Prednisone Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of Dose Limiting Toxicity
Timepoint [1] 0 0
over the first 28 days of dosing
Secondary outcome [1] 0 0
Determination of pharmacokinetic parameters - Tmax
Timepoint [1] 0 0
over the first 28 days of dosing
Secondary outcome [2] 0 0
Determination of pharmacokinetic parameters - Cmax
Timepoint [2] 0 0
over the first 28 days of dosing
Secondary outcome [3] 0 0
Determination of pharmacokinetic parameters - T1/2
Timepoint [3] 0 0
over the first 28 days of dosing
Secondary outcome [4] 0 0
Preliminary Evidence of efficacy/anti tumor activity - PSA levels
Timepoint [4] 0 0
through study completion, average of 12 months
Secondary outcome [5] 0 0
Preliminary Evidence of efficacy/anti tumor activity - RECIST
Timepoint [5] 0 0
through study completion, average of 12 months

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/11/2023
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St. George Private Hospital - Kogarah
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research - Bedford Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pellficure Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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). Once the MTD is defined, the dose expansion phase
is used to define the recommended phase 2 dose.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04677855
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04677855