Metastatic Castration-Resistant Prostate Cancer
Conditions
Brief 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
Interventions
DRUGPCUR - 101
PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
Sponsors
Pellficure Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * concomitant use of therapeutic anticoagulation * history of or current cardiac issues * received external beam radiation therapy within 4 weeks * CTCAE Grade \> 2 neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicities and Adverse Events | 28 days | determined by type and severity using the most recent version of the CTCAE criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response | up to 2 years | a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria |
| Toxicities and adverse events | up to 2 years | determined by type and severity using the most recent version of the CTCAE criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Serum Cytoine IL-6 | up to 2 years | Blood based biomarker |
| Measurement of Urine Polyamines | up to 2 years | Urine based biomarker |
Countries
United States
Outcome results
None listed