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NCT04038437 · ClinicalTrials.gov registry record · Phase 1
A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML
A Phase 1 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT04038437 is a Phase 1 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 35 participants.
The verdict
NCT04038437, a Phase 1 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
Study CPX351-103 is an open-label, multicenter, phase 1b, safety and PK study to determine the MTD of the combination of CPX 351 and venetoclax when administered to subjects with newly diagnosed AML who are unfit for intensive chemotherapy (ICT) and to determine the recommended phase 2 dose (RP2D) for the Expansion Phase. This study will comprise 2 phases: a Dose Exploration Phase (Part 1) and an Expansion Phase (Part 2), in which all subjects will receive a combination of CPX-351 and venetoclax.
Interventions
- DRUG Venetoclax
- DRUG CPX-351
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2022-09-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04038437
The ClinicalTrials.gov registry entry for NCT04038437 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT04038437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04038437 about?
NCT04038437 is a clinical study titled "A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML". Study CPX351-103 is an open-label, multicenter, phase 1b, safety and PK study to determine the MTD of the combination of CPX 351 and venetoclax when administered to subjects with newly diagnosed AML who are unfit for intensive chemotherapy (ICT) and to determine the recommended phase 2 dose (RP2D) f...
What is the current status of trial NCT04038437?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-10-15. Estimated completion is 2022-09-24.
What interventions are being tested in trial NCT04038437?
The interventions under investigation include: Venetoclax (DRUG), CPX-351 (DRUG).
Who is sponsoring clinical trial NCT04038437?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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