Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04205903
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2019-06-18
Brief Title:
Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase IbII Study of the Safety and Pharmacology of Nilotinib to Prevent Paclitaxel-Induced Peripheral Neuropathy in Patients With Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII 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
Detailed Description:
PRIMARY OBJECTIVES
I To determine the recommended phase 2 dose RP2D of nilotinib hydrochloride monohydrate nilotinib in combination with paclitaxel Phase Ib II To determine the toxicity profile based on Common Terminology Criteria for Adverse Events CTCAE version v 50 of nilotinib in combination with paclitaxel Phase Ib III To assess the efficacy of nilotinib versus vs placebo in preventing paclitaxel-induced neuropathy when administered in combination with paclitaxel as measured by patient reported outcomes using Chemotherapy-Induced Peripheral Neuropathy CIPN-20 and Brief Pain Inventory BPI-20 Phase II
SECONDARY OBJECTIVES
I To determine the effect of paclitaxel on pharmacokinetics PK of nilotinib in the study population Phase Ib II To determine the effect of nilotinib on PK of paclitaxel in the study population Phase Ib III To evaluate the effect of paclitaxel on PK of nilotinib in the study population Phase II
OUTLINE This is a phase Ib dose-escalation study of nilotinib hydrochloride monohydrate followed by phase a II study
PHASE Ib Paclitaxel will be given weekly on days 1 8 15 of every 21 days at a starting dose of 80mgm2 Nilotinib will be 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 During the cycle 1 PK will be obtained at baseline during and up to 24 hours after paclitaxel or nilotinib administration on the days 1 7 8 Patients will continue paclitaxel without nilotinib after cycle 1 as part of standard of care at the discretion of the treating investigator
PHASE II Patients are randomized to 1 of 2 groups
GROUP I 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 Patients receive paclitaxel IV on days 1 8 and 15 In cycle 1 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
After completion of study treatment patients are followed up at 3 and 6 months
I To determine the recommended phase 2 dose RP2D of nilotinib hydrochloride monohydrate nilotinib in combination with paclitaxel Phase Ib II To determine the toxicity profile based on Common Terminology Criteria for Adverse Events CTCAE version v 50 of nilotinib in combination with paclitaxel Phase Ib III To assess the efficacy of nilotinib versus vs placebo in preventing paclitaxel-induced neuropathy when administered in combination with paclitaxel as measured by patient reported outcomes using Chemotherapy-Induced Peripheral Neuropathy CIPN-20 and Brief Pain Inventory BPI-20 Phase II
SECONDARY OBJECTIVES
I To determine the effect of paclitaxel on pharmacokinetics PK of nilotinib in the study population Phase Ib II To determine the effect of nilotinib on PK of paclitaxel in the study population Phase Ib III To evaluate the effect of paclitaxel on PK of nilotinib in the study population Phase II
OUTLINE This is a phase Ib dose-escalation study of nilotinib hydrochloride monohydrate followed by phase a II study
PHASE Ib Paclitaxel will be given weekly on days 1 8 15 of every 21 days at a starting dose of 80mgm2 Nilotinib will be 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 During the cycle 1 PK will be obtained at baseline during and up to 24 hours after paclitaxel or nilotinib administration on the days 1 7 8 Patients will continue paclitaxel without nilotinib after cycle 1 as part of standard of care at the discretion of the treating investigator
PHASE II Patients are randomized to 1 of 2 groups
GROUP I 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 Patients receive paclitaxel IV on days 1 8 and 15 In cycle 1 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
After completion of study treatment patients are followed up at 3 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-03146 | REGISTRY | None | None |
| R01CA238946 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchR01CA238946 |