Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206837
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-12-13
Brief Title:
A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B2 OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY PK AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT ARV-471PF-07850327 AN ORAL PROTEOLYSIS TARGETING CHIMERA IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ERHER2- ADVANCED OR METASTATIC BREAST CANCER
Status:
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 study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060 Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer This type of cancer would have spread from where it started breast to other parts of the body and would be tough to treat The study is seeking for participants who have breast cancer that
is hard to treat advanced and may have spread to other organs metastatic
is sensitive to hormonal therapy it is called estrogen receptor positive
is no longer responding to treatments taken before starting this study
All the participants will receive vepdegestrant and PF-07220060 Both medicines will be taken by mouth The medicines will be taken at home The experience of people receiving the study medicines will be studied This will help see if the study medicines are safe and effective Participants will continue to take vepdegestrant and PF-07220060 until
their cancer is no longer responding or
side effects become too severe They will have visits at the study clinic about every 4 weeks
is hard to treat advanced and may have spread to other organs metastatic
is sensitive to hormonal therapy it is called estrogen receptor positive
is no longer responding to treatments taken before starting this study
All the participants will receive vepdegestrant and PF-07220060 Both medicines will be taken by mouth The medicines will be taken at home The experience of people receiving the study medicines will be studied This will help see if the study medicines are safe and effective Participants will continue to take vepdegestrant and PF-07220060 until
their cancer is no longer responding or
side effects become too severe They will have visits at the study clinic about every 4 weeks
Detailed Description:
C4891026 is a prospective open-label multicenter Phase 1b2 study to evaluate the safety antitumor activity and pharmacokinetic PK of vepdegestrant in combination with PF-07220060 in the treatment of participants with Estrogen Receptor PositiveHuman Epidermal Growth Factor Receptor 2 Negative ERHER2- Advanced or Metastatic Breast Cancer
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 |
|---|---|---|---|
| 2023-508130-33-00 | REGISTRY | None | None |
| TACTIVE-K | OTHER | Alias Study Number | None |