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Nilotinib for Preventing Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Phase 1
Recruiting
Led By Nicole Williams, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
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 up to 6 months
Awards & highlights

Summary

This trial is testing the side effects and best dose of nilotinib to prevent numbness and tingling caused by chemotherapy in stage I-III breast cancer patients.

Who is the study for?
This trial is for men and women with stage I-III breast cancer who are about to receive paclitaxel therapy. Participants must have certain blood cell counts within normal ranges, no severe heart or kidney issues, and agree to use contraception if they can have children. People with gastrointestinal problems affecting drug absorption, metastatic disease, unresolved severe side effects from past treatments (except hair loss), current pregnancy or breastfeeding, specific allergies to the drugs used in this study, uncontrolled illnesses that could affect participation, or those using certain other medications cannot join.Check my eligibility
What is being tested?
The trial is testing whether nilotinib can prevent numbness and tingling caused by chemotherapy (specifically paclitaxel) in patients with early-stage breast cancer. It's a phase Ib/II study which means it's looking at the best dose of nilotinib for safety and effectiveness while also trying to find out how well it works for preventing nerve damage known as peripheral neuropathy.See study design
What are the potential side effects?
Nilotinib may cause side effects like rash, nausea, headache, fatigue, muscle pain; there might be changes in liver enzymes or blood counts. Paclitaxel can lead to allergic reactions during infusion and long-term nerve damage resulting in numbness or tingling sensations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

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 (Phase Ib)
Recommended phase II dose (RP2D) of nilotinib in combination with paclitaxel (Phase Ib)
Total sensory neuropathy scores (Phase II)
Secondary outcome measures
Incidence of adverse events (Phase II)
Severity and onset of all six sensory symptoms on CIPN 20 (Phase II)
Other outcome measures
Evaluate effects of nilotinib and paclitaxel (Phase Ib) on patients through Pharmacokinetics (PK) for clinical significant interactions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (paclitaxel, nilotinib hydrochloride monohydrate)Experimental Treatment4 Interventions
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Group II (paclitaxel, placebo)Placebo Group3 Interventions
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive placebo PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Nilotinib
FDA approved

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,584 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,381 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Nicole Williams, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
4 Previous Clinical Trials
218 Total Patients Enrolled
1 Trials studying Breast Cancer
62 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: Group I (paclitaxel, nilotinib hydrochloride monohydrate), Group II (paclitaxel, placebo)
~4 spots leftby Jul 2025
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