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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
Men or Women with a known diagnosis of breast cancer stages I-III
Be eligible for weekly or dose dense single agent paclitaxel therapy based on physician assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with stages I-III breast cancer.
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Your doctor thinks you can receive weekly or closely spaced doses of paclitaxel by itself.
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Your ability to perform daily activities without help is not more than a little bit limited.

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
320 Previous Clinical Trials
290,187 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,638 Previous Clinical Trials
40,929,799 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved a combination of paclitaxel and nilotinib hydrochloride monohydrate for human use?

"Our experts at Power judged Group I (paclitaxel, nilotinib hydrochloride monohydrate) to be relatively unsafe with a score of 1 due to the limited evidence available from phase one trials that deem it both efficacious and safe."

Answered by AI

Is this study currently accessible to participants?

"As indicated on the clinicaltrials.gov website, this research study is still in pursuit of participants. It was first published on December 11th 2020 and updated most recently on February 24th 2023."

Answered by AI

How many individuals have taken part in this medical experiment?

"Correct. Per the information posted on clinicaltrials.gov, this study is presently recruiting participants as of February 24th 2023 and originally began seeking patients December 11th 2020. The trial requires up to 20 volunteers at one medical centre."

Answered by AI

What therapeutic effects does Group I (paclitaxel, nilotinib hydrochloride monohydrate) typically produce?

"Group I (paclitaxel, nilotinib hydrochloride monohydrate) is a combination of drugs utilized to treat myeloid leukemia, chronic phase. Additionally, it may have beneficial effects on non-small cell lung cancer metastasis and refractory accelerated phase chronic myeloid leukemia."

Answered by AI

What other research initiatives have been conducted that focused on the combination of paclitaxel and nilotinib hydrochloride monohydrate?

"Presently, there are 787 trials underway that specifically focus on Group I (paclitaxel, nilotinib hydrochloride monohydrate), with 219 in their final phase. Woolloongabba, Queensland is the epicentre of research for this group; however 43561 sites across the globe have studies related to it running at any given moment."

Answered by AI
~5 spots leftby Apr 2025