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NCT02319018 · ClinicalTrials.gov registry record · Phase 1

Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors

A Phase 1 study of Malignant Digestive System Neoplasm, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
5
Study locations

NCT02319018 is a Phase 1 study of Malignant Digestive System Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 689-participant average among 11 other Malignant Digestive System Neoplasm trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT02319018, a Phase 1 study of Malignant Digestive System Neoplasm, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
5
Study locations

Study Summary

This phase I trial studies the side effects and best dose of alisertib when given together with combination chemotherapy in treating patients with gastrointestinal tumors. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving alisertib with more than one drug (combination chemotherapy) may be a better treatment for gastrointestinal tumors.

Interventions

  • DRUG Fluorouracil
  • DRUG Oxaliplatin
  • OTHER Laboratory Biomarker Analysis
  • DRUG Leucovorin Calcium
  • DRUG Alisertib

Study Locations (5)

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit

Tennessee

  • Vanderbilt University/Ingram Cancer Center - Nashville

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2015-08-27
Est. Completion 2018-09-29
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02319018

The ClinicalTrials.gov registry entry for NCT02319018 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 689-participant average among 11 other Malignant Digestive System Neoplasm trials with a reported enrollment target (98% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malignant Digestive System Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.

NCT02319018 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Connecticut, Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT02319018 about?

NCT02319018 is a clinical study titled "Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors". This phase I trial studies the side effects and best dose of alisertib when given together with combination chemotherapy in treating patients with gastrointestinal tumors. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,...

What is the current status of trial NCT02319018?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-08-27. Estimated completion is 2018-09-29.

What conditions does trial NCT02319018 study?

This clinical trial studies the following conditions: Malignant Digestive System Neoplasm.

What interventions are being tested in trial NCT02319018?

The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Leucovorin Calcium (DRUG), Alisertib (DRUG).

Who is sponsoring clinical trial NCT02319018?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02319018 being conducted?

This trial has 5 study locations across Connecticut, Maryland, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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