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Dasatinib for Preventing Neuropathy in Gastrointestinal Cancer
Phase 1
Waitlist Available
Led By Anne M Noonan, MBBChBAO, MSc
Research Sponsored by Anne Noonan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 1, 2, and 14
Awards & highlights
Study Summary
This trial is studying side effects and best dose of dasatinib to prevent damage to nerves caused by oxaliplatin in patients with gastrointestinal cancers receiving FOLFOX regimen.
Who is the study for?
This trial is for adults with stage II, III, or IV gastrointestinal cancers suitable for FOLFOX6 chemotherapy (with/without bevacizumab). Participants must have good organ function, controlled blood pressure, minimal pre-existing neuropathy (grade 1 or less), and agree to use contraception. Prior treatments are allowed if neuropathy is low grade.Check my eligibility
What is being tested?
The study tests dasatinib's ability to prevent nerve damage caused by oxaliplatin in patients receiving FOLFOX chemotherapy. It explores the best dose of dasatinib and monitors side effects during treatment with this regimen.See study design
What are the potential side effects?
Possible side effects include those from FOLFOX chemotherapy like fatigue, digestive issues, and low blood counts. Dasatinib may cause fluid retention, bleeding problems, muscle pain and could affect heart rhythm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, days 1, 2, and 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 1, 2, and 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Recommended phase II dose (RP2D) of dasatinib
Other outcome measures
Dasatinib on pharmacokinetics (PK) of oxaliplatin
Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Atrial fibrillation
2%
Delirium
2%
Lower gastrointestinal hemorrhage
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Myocardial infarction
2%
Typhlitis
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (dasatinib, mFOLFOX, bevacizumab)Experimental Treatment7 Interventions
Patients receive oxaliplatin IV over 2 hours, leucovorin IV over 2 hours, fluorouracil slow IV push over 2-4 minutes followed by continuous infusion over 46 hours on days 1 and 15. Patients also receive dasatinib PO QD on days 14, 15, and 28 of cycle 1 and day 1 of cycle 2. Patients may receive bevacizumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to cycle 3 day 1 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Oxaliplatin
2011
Completed Phase 4
~2560
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Leucovorin Calcium
2011
Completed Phase 3
~12310
Dasatinib
2012
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
Anne NoonanLead Sponsor
1 Previous Clinical Trials
53 Total Patients Enrolled
Anne M Noonan, MBBChBAO, MScPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Prevention (dasatinib, mFOLFOX, bevacizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Dasatinib obtained governmental sanction for use?
"Due to limited data regarding dasatinib's efficacy and safety, our team at Power gauged its risk level as a 1 on a scale of 1-3."
Answered by AI
What is the highest number of participants in this medical experiment?
"Affirmative. As per the details available on clinicaltrials.gov, this research trial is currently recruiting participants with 10 enrollees needed for a single site. The trial was first posted on September 2nd 2020 and has been updated as recently as April 25th 2022."
Answered by AI
What specific conditions has Dasatinib proven to be beneficial for?
"Dasatinib is an effective treatment for arthritic joints, rectal carcinoma, and non-small cell lung cancer which has spread locally but not developed squamous cells."
Answered by AI
Is there an ongoing enrollment process for participants in this clinical research?
"Clinicaltrials.gov reveals that enlistment for this investigation is ongoing, having been first posted on September 2nd 2020 and last modified on April 25th 2022."
Answered by AI
What additional research has been done utilizing Dasatinib?
"Currently, 893 clinical trials involving Dasatinib are underway with 264 of them taking place in Phase 3. Of these trials, there are 41209 sites located around the world; a notable concentration is found specifically in Guangzhou, Guangdong."
Answered by AI
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