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COMPLETED Phase 1

Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors

NCT02319018 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02319018

The ClinicalTrials.gov registry entry for NCT02319018 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02319018 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Connecticut, Maryland, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02319018?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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