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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: Completed Phase 1 study, sponsored by Emory University.
NCT03507491 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The maximum tolerated dose (MTD) of nab-paclitaxel administered intravenously weekly every 3 of 4 weeks in combination with gemcitabine in children with refractory/relapsed non-CNS solid tumors will be determined. The MTD is empirically defined as the highest dose level at which there is no more than one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. The MTD will be determined during Cycle 1 (each cycle is 28 days)
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 |
What the finished NCT03507491 record still lists
NCT03507491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT03507491 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03507491's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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