Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03854903
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-21
First Post:
2019-02-21
Brief Title:
WI231696 Bosutinib Palbocicilib and Fulvestrant for HRHER2- Advanced Breast Cancer Refractory to a CDK46 Inhibitor
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Phase I Trial of Palbociclib and Bosutinib With Fulvestrant in Patients With Metastatic Hormone Receptor Positive and HER2 Negative HR HER2- Breast Cancer Refractory to an Aromatase Inhibitor and a CDK46 Inhibitor ASPIRE - WI231696
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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 is an open-label single-arm phase I trial It is designed with a conservative dose escalation plan to ensure patients safety and with a strong translational component to inform if target inhibition is achieved With concerns regarding safety based on extensive available pharmacokinetic data and clinical efficacy experience bosutinib will be given 5-days in a row followed by 2 days rest in a weekly basis instead of daily
The protocol will enroll patients per 33 escalation design The Dose Limiting Toxicity DLT observation period is 28 days At the end of DLT observation period of each cohort of 3 patients decision will be made regarding further escalation or de-escalation according to this plan Once the MTD of the combination is reached the safety data will be analyzed There will be no dose reductions during DLT observation period Dose reduction within patients individually is allowed after the 4-week DLT observation period Treatment in this phase I trial will be administered until there is disease progression or unacceptable toxicity
The protocol will enroll patients per 33 escalation design The Dose Limiting Toxicity DLT observation period is 28 days At the end of DLT observation period of each cohort of 3 patients decision will be made regarding further escalation or de-escalation according to this plan Once the MTD of the combination is reached the safety data will be analyzed There will be no dose reductions during DLT observation period Dose reduction within patients individually is allowed after the 4-week DLT observation period Treatment in this phase I trial will be administered until there is disease progression or unacceptable toxicity
Detailed Description:
None
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