Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05355701
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-04-26
Brief Title:
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY TOLERABILITY PHARMACOKINETICS AND ANTI TUMOR ACTIVITY OF PF-07799933 ARRY-440 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
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 clinical trial is to learn about the safety and effects of the study medicine called PF-07799933 administered as a single agent and in combination with other study medicines called binimetinib in people with solid tumors
This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called BRAF and available treatments are no longer effective in controlling their cancer
All participants in this study will receive PF-07799933 PF-07799933 comes as a tablet to take by mouth 2 times a day Depending on the part of the study participants may also receive another study medicine
People with melanoma or other solid tumors may also receive binimetinib Binimetinib comes as a tablet to take by mouth 2 times a day
People with colorectal cancer may also receive cetuximab Cetuximab will be given weekly or every two weeks in the clinic as a shot given in the vein or port intravenous IV
Participants may receive the study medicines for about 2 years The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic
This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called BRAF and available treatments are no longer effective in controlling their cancer
All participants in this study will receive PF-07799933 PF-07799933 comes as a tablet to take by mouth 2 times a day Depending on the part of the study participants may also receive another study medicine
People with melanoma or other solid tumors may also receive binimetinib Binimetinib comes as a tablet to take by mouth 2 times a day
People with colorectal cancer may also receive cetuximab Cetuximab will be given weekly or every two weeks in the clinic as a shot given in the vein or port intravenous IV
Participants may receive the study medicines for about 2 years The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BRAF Class 2 | OTHER | Alias Study Number | None |