Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04553133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2020-08-21
Brief Title:
PF-07104091 as a Single Agent and in Combination Therapy
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
PHASE 12A DOSE ESCALATION FINDING AND EXPANSION STUDY EVALUATING SAFETY TOLERABILITY PHARMACOKINETICS PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION 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:
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose MTD andor select the Recommended Phase 2 dose RP2D for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung breast and ovarian cancers
Detailed Description:
Study C4161001 is a Phase 1 open label multi dose multi center dose escalation safety pharmacokinetic PK and pharmacodynamic study of PF-07104091 in adult patients with advanced or metastatic small cell lung cancer SCLC advanced platinum resistant epithelial ovarian cancerfallopian tube cancerprimary peritoneal cancer locally recurrentadvanced or metastatic triple negative breast cancer TNBC HR-positive HER2-negative advanced or mBC advanced or metastatic non-small cell lung cancer NSCLC This two part study will assess the safety and tolerability of increasing dose levels of PF-07104091 in Part 1 and establish the recommended Phase 2 dose RP2D in 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001679-15 | EUDRACT_NUMBER | None | None |