Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03620318
Status:
AVAILABLE
Last Update Posted:
2020-05-22
First Post:
2018-08-02
Brief Title:
Individual Patient Compassionate Use of Crenolanib
Sponsor:
Arog Pharmaceuticals Inc
Organization:
Arog Pharmaceuticals Inc
Study Overview
Official Title:
Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha PDGFRa Mutations PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 FLT3 Mutations
Status:
AVAILABLE
Status Verified Date:
2024-08
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:
Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease with no other viable therapy options who is not eligible for clinical trials This program is designed to evaluate the requests on a patient by patient basis
Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha PDGFRA-D842V or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 FLT3-ITD or point mutations within the tyrosine kinase domain TKD of FLT3 FLT3-TKD
Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha PDGFRA-D842V or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 FLT3-ITD or point mutations within the tyrosine kinase domain TKD of FLT3 FLT3-TKD
Detailed Description:
This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing
Institutional Review Board-Independent Ethics Committee approval must be granted before The experimental intervention will be administered over 28-day cycles Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies
There must be adequate understanding of the indication for the requested use
Institutional Review Board-Independent Ethics Committee approval must be granted before The experimental intervention will be administered over 28-day cycles Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies
There must be adequate understanding of the indication for the requested use
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