NCT06457919 A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
| NCT ID | NCT06457919 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2027-06 |
Trial Parameters
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Brief Summary
The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria: * Participants ≥ 18 years old, with signed informed consent * Histologically confirmed carcinoma of the prostate (neuroendocrine differentiation is allowed, but pure small cell carcinoma is not permitted) * Metastatic disease documented by at least 2 bone lesions on whole body radionuclide bone scan, or soft tissue disease documented by computed tomography (CT) scan/magnetic resonance imaging (MRI). Note: Metastatic disease seen only on PET imaging does not qualify. * Current ongoing therapy and observed tolerance with full standard dose of abiraterone acetate (1000 mg QD) or enzalutamide (160 mg QD) at the time of study entry. Enzalutamide or abiraterone acetate must have been started at least 90 days before screening assessments. An interruption of dosing of a maximum of 30 days is permitted prior to resuming the agent. Please note: Patients who are on a reduced dose or are intolerant of abiraterone acetate or enzalutamide at screening will not be eligible for stu
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