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NCT05252390 · ClinicalTrials.gov registry record · Phase 1
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Nuvation Bio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT05252390 is a Phase 1 study that was terminated before completion, run by Nuvation Bio. The registered enrollment target is 82 participants.
The verdict
NCT05252390, a Phase 1 study, was terminated before completion, sponsored by Nuvation Bio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Interventions
- DRUG Olaparib
- DRUG Enzalutamide
- DRUG NUV-868
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05252390
The ClinicalTrials.gov registry entry for NCT05252390 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuvation Bio, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Olaparib is the first listed.
NCT05252390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05252390 about?
NCT05252390 is a clinical study titled "NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors". NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and...
What is the current status of trial NCT05252390?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2022-03-29. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT05252390?
The interventions under investigation include: Olaparib (DRUG), Enzalutamide (DRUG), NUV-868 (DRUG).
Who is sponsoring clinical trial NCT05252390?
This trial is sponsored by Nuvation Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
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