Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02584634
Status:
TERMINATED
Last Update Posted:
2023-07-07
First Post:
2015-10-21
Brief Title:
Study to Evaluate Safety Efficacy Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC Javelin Lung 101
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1B2 OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY EFFICACY PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB MSB0010718C IN COMBINATION WITH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated since there was no need for further safety or efficacy data to be collected The participants having benefit from the Investigational treatments have been moved to a continuation study NCT05059522
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 evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922
Detailed Description:
This is a Phase 1b2 open label multi center multiple dose safety pharmacokinetic and pharmacodynamic study of Group A and Group B in cohorts of adult patients with locally advanced or metastatic NSCLC
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 |
|---|---|---|---|
| JAVELIN LUNG 101 | OTHER | Alias Study Number | None |
| 2015-001879-43 | EUDRACT_NUMBER | None | None |