drugset / Trial / NCT06059118
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
Phase 2
Recruiting
50 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Panbela Therapeutics, Inc. · collabProstate Cancer Foundation · collabUnited States Department of Defense · collab
NaSingle-groupOpen-labelTreatment
Summary
Asymptomatic patients with metastatic castrate resistant prostate cancer (mCRPC) without pain due to prostate cancer will be treated on an open label study to evaluate effectiveness of sequential treatment with the combination of difluoromethylornithine (DFMO) and high dose testosterone in sequence with enzalutamide to improve primary and secondary outcomes.
Timeline
- Start
- 2023-10-04
- Primary completion
- 2027-01-04
- Completion
- 2029-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eflornithine | Small molecule | 1000 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Subject | Testosterone Cypionate | Small molecule | 400 mg | Intramuscular |
| Background | Decapeptyl | Unknown | — | — |
| Background | Degarelix | Other / unclassified | — | — |
| Background | Goserelin | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | — |
| Background | Relugolix | Small molecule | — | — |