Study of PCUR-101 in Combination With ADT in Patients With mCRPC
Key facts
- Who runs it
- Pellficure Pharmaceuticals, Inc
- Where
- Ann Arbor and Omaha, United StatesSee the 2 sitesAlso in 1 other country, 2 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 7 people enrolled
- Started
- 30 Mar 2021
- Ended
- 20 Nov 2023
- Type of study
- Interventional, 4 groups
- Treatments tested
- PCUR-101
- Dutasteride 0.5 mg
- Abiraterone and Prednisone
- Record updated
- 10 April 2024
- Why it stopped
- Business Decision due to insufficient enrollment
Who can take part
- Age
- 18 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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 take part
- other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks
- Concomitant use of warfarin
- Prior exposure to PCUR-101
- Received wide-field external beam radiation therapy within 4 weeks
- Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- Use of opiate analgesics for prostate cancer pain or non-cancer pain
- History of bleeding disorder
- History of seizure disorder
- History of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia
- Visceral metastasis excluding lymph nodes
- Moderate to severe neuropathy
Where in United States
Also in 1 other country, 2 sites
- University of MichiganAnn Arbor, United States
- Nebraska Cancer SpecialistOmaha, United States
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- PCUR-101 Dose EscalationTreatment being tested
PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase
Treatment: PCUR-101
- PCUR-101 Dose Expansion Cohort 1Treatment being tested
PCUR-101 dosed orally once per day in 28 day cycles
Treatment: PCUR-101
- PCUR-101 Dose Expansion Cohort 2Treatment being tested
PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles
Treatment: PCUR-101 and Dutasteride 0.5 mg
- PCUR-101 Dose Expansion Cohort 3Treatment being tested
PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles
Treatment: PCUR-101 and Abiraterone and Prednisone
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 10 April 2024