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

NCT03507491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-04

No results posted yet for this 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

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine will be administered intravenously once weekly over 60 minutes every 3 out of four weeks. The dose of gemcitabine will start at 675 mg/m2/dose. If the MTD has been exceeded at the Dose Level 1, then the subsequent cohort of participants will be treated with gemcitabine at a dose of 500 mg/m2/dose (Dose Level 0).

DRUG

Nab-paclitaxel

Nab-Paclitaxel will be administered intravenously over 30 minutes once weekly every 3 out of 4 weeks. Nab-paclitaxel will be administered prior to administration of gemcitabine. The starting dose of nab-paclitaxel will be 180 mg/m2/dose (dose level 1). Dose levels for subsequent groups of subjects are 210 mg/m2/dose (for dose level 2) and 240 mg/m2/dose (for dose level 3).

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Thomas Cash, MD, MSc · Emory University

  • Jonathan Metts, MD · Johns Hopkins All Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2024-02-02
Completion
2024-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507491 on ClinicalTrials.gov