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NCT04164069 · ClinicalTrials.gov registry record · Phase 1
Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab
A Phase 1 study, sponsored by Anne Noonan.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT04164069: Completed Phase 1 study, sponsored by Anne Noonan.
NCT04164069 is a Phase 1 study that has completed, run by Anne Noonan. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04164069, a Phase 1 study, has completed, sponsored by Anne Noonan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase Ib trial studies side effects and best dose of dasatinib in preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who are receiving FOLFOX regimen with or without bevacizumab. Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin (FOLFOX regimen), 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. However, the buildup of oxaliplatin in the cranial nerves can result in damage or the nerves. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Blocking these enzymes may reduce oxaliplatin-induced peripheral neuropathy.
Primary Outcome
The RP2D will be defined as the lowest intermittent dose of dasatinib that affects serum biomarkers of OCT2 without influencing the pharmacokinetic properties of oxaliplatin.
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Dasatinib
- BIOLOGICAL Bevacizumab
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2023-06-22 |
| Phase | Phase 1 |
What the finished NCT04164069 record still lists
NCT04164069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT04164069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04164069 about?
NCT04164069 is a clinical study titled "Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab". This phase Ib trial studies side effects and best dose of dasatinib in preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who are receiving FOLFOX regimen with or without bevacizumab. Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxalip...
What is the current status of trial NCT04164069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-09-02. Estimated completion is 2023-06-22.
What interventions are being tested in trial NCT04164069?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Dasatinib (DRUG), Bevacizumab (BIOLOGICAL), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT04164069?
This trial is sponsored by Anne Noonan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04164069's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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