Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02473497
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-06-26
First Post:
2015-06-12
Brief Title:
Crizotinib Xalkori Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
CRIZOTINIB XALKORIREGISTERED EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULES
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-06
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:
This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric defined as age 18 years patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib
Detailed Description:
Crizotinib is indicated in the US for the treatment of patients with metastatic non-small cell lung cancer NSCLC whose tumors are anaplastic lymphoma kinase ALK-positive as detected by an FDA-approved test Commercially available dosage forms are 250 mg and 200 mg capsules This expanded access protocol EAP is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| A8081056 | OTHER | Alias Study Number | None |