Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05262400
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-02-21
Brief Title:
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With PF-07104091 In Participants With Breast Cancer and Solid Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1B2 OPEN-LABEL MULTICENTER DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY TOLERABILITY PHARMACOKINETICS PHARMACODYNAMICS AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this clinical trial is to learn about the safety and effects of the study medicine called PF-07220060 and PF-07104091 in people with breast cancer This clinical study consists of 2 parts part 1 and part 2 In part 1 we are seeking participants who
Have been diagnosed with Breast Cancer BC of either types
Have HR HER2- BC
Refractory HR-positiveHER2-positive BC
Have other solid tumors other than BC
In part 2 we are seeking participants who
-Have HR-positiveHER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091 In part 2 participants will take 1 of 2 study medicine combinations This will help us decide the highest amount of study medicines that can be safety given to people All participants in this study will receive PF-07220060 with PF-07104091 by mouth We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective Participants will take part in this study for about 2 years During this time they will receive the study medicine an x-ray imaging and will be observed for safety and effects of the study medicines
Have been diagnosed with Breast Cancer BC of either types
Have HR HER2- BC
Refractory HR-positiveHER2-positive BC
Have other solid tumors other than BC
In part 2 we are seeking participants who
-Have HR-positiveHER2-negative BC Part 1 will include increasing doses of PF-07220060 with PF-07104091 In part 2 participants will take 1 of 2 study medicine combinations This will help us decide the highest amount of study medicines that can be safety given to people All participants in this study will receive PF-07220060 with PF-07104091 by mouth We will compare participant experiences to help us determine if PF-07220060 with PF-07104091 is safe and effective Participants will take part in this study for about 2 years During this time they will receive the study medicine an x-ray imaging and will be observed for safety and effects of the study medicines
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002173-28 | EUDRACT_NUMBER | None | None |