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NCT03507491 · ClinicalTrials.gov registry record · Phase 1
Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03507491 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 24 participants.
The verdict
NCT03507491, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a research study for people who have a solid tumor that was not effectively treated by conventional therapy or for which there is no known effective therapy. This is a phase I study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and nab-paclitaxel will be given intravenously, once a week for 3 out of 4 weeks, for a 28-day cycle. The goals of this study are: * To find the highest dose of nab-paclitaxel that can be safely given in combination with gemcitabine without causing severe side effects * To learn what kind of side effects nab-paclitaxel given in combination with gemcitabine can cause * To learn more about the pharmacology (how the body handles the drug) of nab-paclitaxel given in combination with gemcitabine * To evaluate tumor tissue for levels of certain proteins that may help with predicting who will benefit most from treatment with nab-paclitaxel * To determine whether nab-paclitaxel given in combination with gemcitabine is a beneficial treatment for relapsed and/or refractory solid tumors
Interventions
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03507491
The ClinicalTrials.gov registry entry for NCT03507491 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT03507491 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03507491 about?
NCT03507491 is a clinical study titled "Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors". This is a research study for people who have a solid tumor that was not effectively treated by conventional therapy or for which there is no known effective therapy. This is a phase I study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and nab-paclitaxel will be given i...
What is the current status of trial NCT03507491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-08-27. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT03507491?
The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT03507491?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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