Clinical trial · Interventional
A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
NCT03137758CI-TRIAL-00043882terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Reformulation of study drug to help reduce the pill burden as higher doses are evaluated.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCUR - 101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Level 1 (50 mg) PCUR-101
- description
- Starting Dose, 3+3 Cohort Design
- interventionNames
- Drug: PCUR - 101
- type
- EXPERIMENTAL
- label
- Level 2 (100 mg) PCUR-101
- interventionNames
- Drug: PCUR - 101
- type
- EXPERIMENTAL
- label
- Level 3 (150 mg) PCUR-101
- interventionNames
- Drug: PCUR - 101
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.