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Completed Phase 1 Interventional

Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

ClinicalTrials.gov ID: NCT03507491

Public ClinicalTrials.gov record NCT03507491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 11:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

AflacST1603: a Phase 1 Study Using Nab-paclitaxel (Abraxane®) in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT03507491
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Emory University
Other
Enrollment
24 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 30 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 26, 2018
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024
Last update posted
Oct 3, 2024

2018 – 2024

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Children's Hospital Colorado Aurora Colorado 80045
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701
Chilldren's Healthcare of Atlanta Atlanta Georgia 30322
Children's Mercy Hospital Kansas City Missouri 64108

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03507491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 3, 2024 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03507491 live on ClinicalTrials.gov.

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