11 Participants Needed

Nilotinib for Preventing Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ohio State University Comprehensive Cancer Center
Must be taking: Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase Ib trial studies the side effects and best dose of nilotinib in preventing paclitaxel-induced peripheral neuropathy in stage I-III breast cancer patients who are receiving paclitaxel therapy. Chemotherapy is the usual or standard treatment for breast cancer. It kills cancer cells and lowers the chance that the cancer will come back. Sometimes, this treatment can cause numbness and tingling, especially in the hands and feet. This is called chemotherapy-induced peripheral neuropathy. This study aims to test the safety and effectiveness, both good and bad, of taking nilotinib in preventing chemotherapy-induced peripheral neuropathy.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as potent CYP3A4 inhibitors and potent OATP1B1 inhibitors, before starting nilotinib. If you are on these medications, you may need to switch to a different one or discontinue them safely.

How does the drug Nilotinib differ from other treatments for preventing chemotherapy-induced peripheral neuropathy in breast cancer?

Nilotinib is unique because it is primarily known as a treatment for chronic myeloid leukemia, and its use for preventing chemotherapy-induced peripheral neuropathy (nerve damage) in breast cancer is novel. Unlike standard treatments, which are limited, Nilotinib's mechanism as a tyrosine kinase inhibitor (a type of drug that blocks certain enzymes) may offer a new approach to managing this condition.12345

Who Is on the Research Team?

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Nicole Williams, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your absolute neutrophil count is at least 1,500 per microliter of blood.
Your doctor thinks you can receive weekly or closely spaced doses of paclitaxel by itself.
Your ability to perform daily activities without help is not more than a little bit limited.
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Exclusion Criteria

You have stomach or intestine problems that could make it hard for your body to absorb nilotinib.
You have cancer that has spread to other parts of your body.
You have had side effects from previous treatments that have not gotten better.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Paclitaxel is given weekly on days 1, 8, 15 of every 21 days, with nilotinib given orally on cycle 1 Days 7, 14 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.

3 weeks
Weekly visits for paclitaxel administration

Phase II Treatment

Patients are randomized to receive either nilotinib or placebo in combination with paclitaxel. Treatment repeats every 21 days for up to 4 cycles.

12 weeks
Weekly visits for paclitaxel administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion at 3 and 6 months.

6 months
Follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nilotinib
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Dose level 3Experimental Treatment4 Interventions
Group II: Dose level 2Experimental Treatment4 Interventions
Group III: Dose level 1Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 126 women treated with taxane-based chemotherapy for breast cancer, 73% reported experiencing chemotherapy-induced peripheral neuropathy (CIPN), which significantly affected their quality of life and physical functioning.
CIPN severity was notably higher in Black or African American women, indicating a need for targeted screening and intervention strategies to address this disparity.
The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice.Simon, NB., Danso, MA., Alberico, TA., et al.[2022]
Chronic sensory neuropathy in chemotherapy patients is influenced by complex interactions between cancer and chemotherapy, which affect neuronal excitability and inflammatory responses, as shown by global transcriptional profiling of dorsal root ganglia.
The study identified Kv3.3 potassium ion channels as a potential contributor to sensory neuron dysfunction, and revealed new behavioral deficits in forelimb placement that were not predicted by previous studies of chemotherapy alone.
Cancer Exacerbates Chemotherapy-Induced Sensory Neuropathy.Housley, SN., Nardelli, P., Carrasco, DI., et al.[2021]
In a study of 1313 patients with stage III colon cancer, a 3-month course of oxaliplatin-based chemotherapy significantly reduced the incidence of long-lasting peripheral sensory neuropathy (PSN) compared to a 6-month course (9.7% vs 24.3%).
The 3-month treatment duration did not compromise disease-free survival (DFS) outcomes, suggesting that a shorter course, particularly with the CAPOX regimen, may be a safer and effective option for patients, especially those with low-risk disease.
Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial.Yoshino, T., Yamanaka, T., Oki, E., et al.[2022]

Citations

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. [2022]
Cancer Exacerbates Chemotherapy-Induced Sensory Neuropathy. [2021]
Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial. [2022]
Impact of chemotherapy-induced peripheral neuropathy on treatment delivery in nonmetastatic breast cancer. [2022]
Neuropathy with vascular endothelial growth factor receptor tyrosine kinase inhibitors: A meta-analysis. [2020]
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