NCT03620318

Individual Patient Compassionate Use of Crenolanib

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
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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)

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.

Conditions

• FLT3-ITD Mutation
• FLT3/TKD Mutation
• PDGFR-Alpha D842V
• PDGFRA Gene Amplification

Interventions

Type	Name	Description
DRUG	Crenolanib besylate

Timeline

• First posted: 2018-08-08
• Last updated: 2024-08-09

Locations

1 site across 1 country: Italy