Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03959891
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2019-05-15
Brief Title:
AKT Inhibitor Ipatasertib With Endocrine and CDK 46 Inhibitor for Patients With Metastatic Breast Cancer TAKTIC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Clinical Trial to Evaluate Safety and Anti-tumor Activity of AKT Inhibitor IpatasertibWith Endocrine Therapy WithWithout CDK 46 Inhibitor for Patients With Metastatic Hormone Receptor Positive Breast Cancer TAKTIC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 study is exploring the safetytolerabtility and preliminary efficacy of the combination of Ipatasertib with Aromatase inhibitor or Fulvestrant for patients with metastatic HR breast cancer
Detailed Description:
This research study is a Phase I clinical trial which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved ipatasertib as a treatment for any disease
The FDA has approved fulvestrant the aromatase inhibitors and palbociclib as treatment options for this disease
This research study will evaluate the safety and tolerability of ipatasertib in combination with an aromatase inhibitor or fulvestrant with or without palbociclib
Resistance to standard of care treatment for people with your type of cancer is common Stopping inhibiting an enzyme called Akt in the cancer cells may overcome resistance to the standard of care treatment Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt Through the different combinations of ipatasertib and the standard of care drugs the chance of cancer cells becoming resistant to the standard of care drugs may decrease causing the cancer cells to stop growing and spreading
The US Food and Drug Administration FDA has not approved ipatasertib as a treatment for any disease
The FDA has approved fulvestrant the aromatase inhibitors and palbociclib as treatment options for this disease
This research study will evaluate the safety and tolerability of ipatasertib in combination with an aromatase inhibitor or fulvestrant with or without palbociclib
Resistance to standard of care treatment for people with your type of cancer is common Stopping inhibiting an enzyme called Akt in the cancer cells may overcome resistance to the standard of care treatment Ipatasertib is a type of inhibitor that is believed to work by inhibiting Akt Through the different combinations of ipatasertib and the standard of care drugs the chance of cancer cells becoming resistant to the standard of care drugs may decrease causing the cancer cells to stop growing and spreading
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