NCT04205903View on ClinicalTrials.gov

Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 11, 2020

Primary Completion Date

June 19, 2024

Study Completion Date

December 18, 2024

Conditions
Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8
Interventions
DRUG

Nilotinib

Given PO

DRUG

Nilotinib Hydrochloride Monohydrate

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.

DRUG

Paclitaxel

Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (1)

43210

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Ohio State University Comprehensive Cancer Center

OTHER

NCT04205903 - Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer | Biotech Hunter | Biotech Hunter