Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408168
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-30
Brief Title:
Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor REPLOT Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor REPLOT Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To find out if the combination of repotrectinib and fulvestrant can control the disease in participants with metastatic invasive lobular carcinoma
Detailed Description:
Primary Objectives
To evaluate the 6-month progression free survival PFS of repotrectinib with or without fulvestrant in HR HER2- mILC patients who received a prior ET in combination with CDK46i
Secondary Objectives
To evaluate the 12-month PFS and median PFS mPFS of repotrectinib with or without fulvestrant in HR HER2- mILC patients who received a prior ET in combination with CDK46i
To evaluate the overall response rate ORR of reporectinib with or without fulvestrant in HR HER2- mILC patients who received a prior ET in combination with CDK46i
To assess the clinical benefit rate CBR median duration of response mDOR and median overall survival mOS
To evaluate the safety and tolerability of repotrectinib alone and in combination with fulvestrant as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v50
ExploratoryCorrelative Objectives
To explore response to repotrectinib based on ROS1 and P120 expression by IHC
To explore if changes in serum thymidine kinase 1 activity TKa between baseline and C1D15 correlates with response
To explore whether changes in circulating tumor DNA ctDNA levels between baseline and C1D15 predict response to repotrectinib
To correlate whole exome sequencing WES and RNA sequencing RNAseq findings with response or lack of to repotrectinib
To explore changes in the tumor microenvironment TME composition using mIF in response to repotrectinib
To evaluate the 6-month progression free survival PFS of repotrectinib with or without fulvestrant in HR HER2- mILC patients who received a prior ET in combination with CDK46i
Secondary Objectives
To evaluate the 12-month PFS and median PFS mPFS of repotrectinib with or without fulvestrant in HR HER2- mILC patients who received a prior ET in combination with CDK46i
To evaluate the overall response rate ORR of reporectinib with or without fulvestrant in HR HER2- mILC patients who received a prior ET in combination with CDK46i
To assess the clinical benefit rate CBR median duration of response mDOR and median overall survival mOS
To evaluate the safety and tolerability of repotrectinib alone and in combination with fulvestrant as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v50
ExploratoryCorrelative Objectives
To explore response to repotrectinib based on ROS1 and P120 expression by IHC
To explore if changes in serum thymidine kinase 1 activity TKa between baseline and C1D15 correlates with response
To explore whether changes in circulating tumor DNA ctDNA levels between baseline and C1D15 predict response to repotrectinib
To correlate whole exome sequencing WES and RNA sequencing RNAseq findings with response or lack of to repotrectinib
To explore changes in the tumor microenvironment TME composition using mIF in response to repotrectinib
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03805 | OTHER | NCI-CTRP Clinical Registry | None |