Ignite Creation Date:
2024-05-06 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03519178
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-26
First Post:
2018-02-22
Brief Title:
A Study of PF-06873600 in People With Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
PHASE 12A DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY TOLERABILITY PHARMACOKINETIC PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 study medicine PF-06873600 when taken alone or with hormone therapy by people with cancer
People may be able to participate in this study if they have the following types of cancer Hormone Receptor positive HR breast cancer Human Epidermal Growth Factor Receptor 2 HER2-negative breast cancer that is advanced or metastatic spread to other parts of the body triple negative breast cancer epithelial ovarian cancer fallopian tube cancer or primary peritoneal cancer
All participants in this study will receive the study medicine by mouth 1 to 2 times a day at home The dose of the study medicine may be changed during the study
Some participants will also receive hormone therapy The hormone therapy will be either letrozole by mouth once a day at home or fulvestrant as a shot into the muscle Fulvestrant will be given every two weeks at the study clinic for the first month and then once a month after that
Participants will take part in this study for at least 7 to 8 months depending on how they respond to the therapy During this time participants will visit the study clinic once a week
People may be able to participate in this study if they have the following types of cancer Hormone Receptor positive HR breast cancer Human Epidermal Growth Factor Receptor 2 HER2-negative breast cancer that is advanced or metastatic spread to other parts of the body triple negative breast cancer epithelial ovarian cancer fallopian tube cancer or primary peritoneal cancer
All participants in this study will receive the study medicine by mouth 1 to 2 times a day at home The dose of the study medicine may be changed during the study
Some participants will also receive hormone therapy The hormone therapy will be either letrozole by mouth once a day at home or fulvestrant as a shot into the muscle Fulvestrant will be given every two weeks at the study clinic for the first month and then once a month after that
Participants will take part in this study for at least 7 to 8 months depending on how they respond to the therapy During this time participants will visit the study clinic once a week
Detailed Description:
This is a Phase 12a open-label multi-center non-randomized multiple dose safety tolerability pharmacokinetic and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy In Part 1A and Part 1C successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding Part 1B with PF-06873600 in combination with endocrine therapy ET This study contains 2 parts dose escalation with single agent Part 1A and 1C and then dose finding with PF-06873600 in combination with endocrine therapy Part 1B followed by dose expansion arms of PF-06873600 in combination with endocrine therapy Part 2
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