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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 1, 2, and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Recommended phase II dose (RP2D) of dasatinib

Other study objectives

Dasatinib on pharmacokinetics (PK) of oxaliplatin

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Hypotension

Hypertension

Intracranial hemorrhage

Enterocolitis

Peripheral motor neuropathy

Small intestinal obstruction

Lower gastrointestinal hemorrhage

Fungemia

Typhlitis

Oropharyngeal pain

Multi-organ failure

Abdominal pain

Hypoxia

Kidney infection

Edema limbs

Sinus bradycardia

Gastric hemorrhage

Myocardial infarction

Diarrhea

Fibrinogen decreased

Aspiration

Atrial fibrillation

Delirium

Endophthalmitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5540

Oxaliplatin

2011

Completed Phase 4

~2890