Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447662
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-29
Brief Title:
A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene
Status:
RECRUITING
Status Verified Date:
2024-09
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 learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies This study also aims to find the best dose
This study is seeking participants who have solid tumors a mass of abnormal cells that forms a lump or growth in the body that
are advanced cancer that doesnt disappear or stay away with treatment and
have a KRAS gene mutation a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers
This includes but limited to the following cancer types
Non-Small Cell Lung Cancer NSCLC Its a type of lung cancer where the cells grow slowly but often spread to other parts of the body
Colorectal Cancer CRC This is a disease where cells in the colon a part of large intestine or rectum grow out of control
Pancreatic ductal adenocarcinoma PDAC This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body Pancreas is a long flat gland that lies in the abdomen behind the stomach Pancreas creates enzymes that help with digestion It also makes hormones that can help control your blood sugar levels
All participants in this study will take the study medication PF-07934040 as pill by mouth twice a day repeating for 21-day or 28-day cycles
Depending on which part of the study participants are enrolled into they will receive the study medication PF-07934040 alone or in combination with other anti-cancer medications These anti-cancer medications will be given in the study clinic by intravenous IV that is directly injected into the veins at various times depending on the treatment during the 21-day or 28-day cycle
Participants can continue to take the study medication PF-07934040 and the combination anti-cancer therapy until their cancer is no longer responding
The study will look at the experiences of people receiving the study medicines This will help see if the study medicines are safe and effective
Participants will be involved in this study for up to 4 years During this time they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle After they have stopped taking the study medication at about at 2 years they will be followed for another two years to see how they are doing
This study is seeking participants who have solid tumors a mass of abnormal cells that forms a lump or growth in the body that
are advanced cancer that doesnt disappear or stay away with treatment and
have a KRAS gene mutation a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers
This includes but limited to the following cancer types
Non-Small Cell Lung Cancer NSCLC Its a type of lung cancer where the cells grow slowly but often spread to other parts of the body
Colorectal Cancer CRC This is a disease where cells in the colon a part of large intestine or rectum grow out of control
Pancreatic ductal adenocarcinoma PDAC This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body Pancreas is a long flat gland that lies in the abdomen behind the stomach Pancreas creates enzymes that help with digestion It also makes hormones that can help control your blood sugar levels
All participants in this study will take the study medication PF-07934040 as pill by mouth twice a day repeating for 21-day or 28-day cycles
Depending on which part of the study participants are enrolled into they will receive the study medication PF-07934040 alone or in combination with other anti-cancer medications These anti-cancer medications will be given in the study clinic by intravenous IV that is directly injected into the veins at various times depending on the treatment during the 21-day or 28-day cycle
Participants can continue to take the study medication PF-07934040 and the combination anti-cancer therapy until their cancer is no longer responding
The study will look at the experiences of people receiving the study medicines This will help see if the study medicines are safe and effective
Participants will be involved in this study for up to 4 years During this time they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle After they have stopped taking the study medication at about at 2 years they will be followed for another two years to see how they are doing
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