At a glance
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A Phase Ib Study of the Safety and Pharmacology of Nilotinib to Prevent Paclitaxel-Induced Peripheral Neuropathy in Patients With Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Nilotinib, Nilotinib Hydrochloride Monohydrate, and 2 other interventions for Anatomic Stage I Breast Cancer AJCC v8 and 19 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Given PO
Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Ancillary studies