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NCT05450965 · ClinicalTrials.gov registry record · Phase 2
Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
A Phase 2 study of Small-cell Lung Cancer and Small Cell Lung Carcinoma, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT05450965: Recruiting Phase 2 study of Small-cell Lung Cancer and Small Cell Lung Carcinoma, sponsored by University of Maryland, Baltimore.
NCT05450965 is a Phase 2 study of Small-cell Lung Cancer and Small Cell Lung Carcinoma that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 37 participants, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05450965, a Phase 2 study of Small-cell Lung Cancer and Small Cell Lung Carcinoma, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair.
Primary Outcome
The proportion of patients having either a complete response (CR) or partial response (PR) (as best response), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Conditions Studied
Interventions
- DRUG Onvansertib
Study Locations (2)
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2022-07-19 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What NCT05450965 shows while recruiting
NCT05450965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Onvansertib is the first listed.
NCT05450965 reports a single indexed study location in Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05450965 about?
NCT05450965 is a clinical study titled "Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer". This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expresse...
What is the current status of trial NCT05450965?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2022-07-19. Estimated completion is 2027-11-30.
What conditions does trial NCT05450965 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT05450965?
The interventions under investigation include: Onvansertib (DRUG).
Who is sponsoring clinical trial NCT05450965?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05450965 being conducted?
This trial has 2 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05450965's enrollment target sits among peer trials
37 60th of 79 higher than 20 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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