Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05082025
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2021-09-02
Brief Title:
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER andor PR Cancers With PI3K PIK3CA PIK3R1 andor PTEN Alterations
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER andor PR Cancers With PI3K PIK3CA PIK3R1 andor PTEN Alterations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study is to evaluate the efficacy and safety of copanlisib in combination with fulvestrant in advanced hormone receptor-positive HR solid tumors harboring alterations that activate the Phosphatidylinositol-3 kinase PI3K pathway
Detailed Description:
Part 1 Dose confirmation
Primary Objective
To evaluate the safety tolerability and dose-limiting toxicities DLT of copanlisib 60 mg administered intravenously IV on Days 1 8 and 15 in combination with fulvestrant 500 mg administered intramuscularly IM on Day 1 and Day 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle to confirm the recommended phase 2 doses RP2D of the combination therapy
Secondary objective
To assess the efficacy of copanlisib administered in combination with fulvestrant as outlined in Part 2 by evaluating the objective response rate ORR
To evaluate additional efficacy measures such as progression-free survival PFS and overall survival OS of copanlisib in combination with fulvestrant
Exploratory Objectives
To investigate target engagement clonal evolution and mechanisms of resistance using tissue and liquid biopsies utilizing circulating tumor DNA ctDNA as outlined in Part 2
Part 2 Dose expansion
Primary objectives
To assess the efficacy of copanlisib administered in combination with fulvestrant as outlined above by evaluating the objective response rate ORR Patients enrolled for Part 1 will be included in this efficacy analysis
Secondary Objectives
To evaluate additional efficacy measures such as PFS and OS of copanlisib in combination with fulvestrant
To evaluate the safety and tolerability of copanlisib in combination with fulvestrant
Exploratory Objectives
To investigate target engagement clonal evolution and mechanisms of resistance using tissue and liquid biopsies utilizing ctDNA
Primary Objective
To evaluate the safety tolerability and dose-limiting toxicities DLT of copanlisib 60 mg administered intravenously IV on Days 1 8 and 15 in combination with fulvestrant 500 mg administered intramuscularly IM on Day 1 and Day 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle to confirm the recommended phase 2 doses RP2D of the combination therapy
Secondary objective
To assess the efficacy of copanlisib administered in combination with fulvestrant as outlined in Part 2 by evaluating the objective response rate ORR
To evaluate additional efficacy measures such as progression-free survival PFS and overall survival OS of copanlisib in combination with fulvestrant
Exploratory Objectives
To investigate target engagement clonal evolution and mechanisms of resistance using tissue and liquid biopsies utilizing circulating tumor DNA ctDNA as outlined in Part 2
Part 2 Dose expansion
Primary objectives
To assess the efficacy of copanlisib administered in combination with fulvestrant as outlined above by evaluating the objective response rate ORR Patients enrolled for Part 1 will be included in this efficacy analysis
Secondary Objectives
To evaluate additional efficacy measures such as PFS and OS of copanlisib in combination with fulvestrant
To evaluate the safety and tolerability of copanlisib in combination with fulvestrant
Exploratory Objectives
To investigate target engagement clonal evolution and mechanisms of resistance using tissue and liquid biopsies utilizing ctDNA
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-2021-09936 | OTHER | NCI-CTRP Clinical Trials Reporting Registry | None |