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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: Completed Phase 1 study of Malignant Digestive System Neoplasm, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-08-27 |
| Est. Completion | 2018-09-29 |
| Phase | Phase 1 |
What the finished NCT02319018 record still lists
NCT02319018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 689-participant average among 11 other Malignant Digestive System Neoplasm trials with a reported enrollment target (98% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
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Where NCT02319018's enrollment target sits among peer trials
14 11th of 11 higher than 1 of 11 other Malignant Digestive System Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Digestive System Neoplasm 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.
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