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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

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

Primary study objectives

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 study objectives

Incidence of adverse events (Phase II)

Severity and onset of all six sensory symptoms on CIPN 20 (Phase II)

Other study objectives

Evaluate effects of nilotinib and paclitaxel (Phase Ib) on patients through Pharmacokinetics (PK) for clinical significant interactions.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

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