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NCT05616624 · ClinicalTrials.gov registry record · Phase 1
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
A Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 3
- Study locations
NCT05616624: Active Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, sponsored by Washington University School of Medicine.
NCT05616624 is a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 31 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05616624, a Phase 1 study of Non-Small Cell Lung Cancer and Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 3
- Study locations
Study Summary
In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Although safety and tolerability has been previously determined in the sarcoma population, dose de-escalations of the chemotherapies in that patient population were required. Therefore, a phase I portion will be incorporated to determine the RP2D of the triplet in this population.
Primary Outcome
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first 4 weeks of treatment. Dose escalations will proceed until the MTD has been reached or until Dose Level 3, and this dose level will then be defined as the Recommended Phase 2 Dose (RP2D).
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Gemcitabine
- DRUG ADI-PEG 20
Study Locations (3)
Illinois
- Northwestern University - Chicago
Missouri
- Washington University School of Medicine - St Louis
Virginia
- Inova Schar Cancer Institute - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2033-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05616624 still lists
NCT05616624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT05616624 reports a single indexed study location in Illinois, Missouri, Virginia.
Frequently Asked Questions
What is clinical trial NCT05616624 about?
NCT05616624 is a clinical study titled "ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers". In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patient...
What is the current status of trial NCT05616624?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2023-04-05. Estimated completion is 2033-12-31.
What conditions does trial NCT05616624 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Small-cell Lung Cancer, Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT05616624?
The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), ADI-PEG 20 (DRUG).
Who is sponsoring clinical trial NCT05616624?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05616624 being conducted?
This trial has 3 study locations across Illinois, Missouri, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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