Individual Patient Compassionate Use of Crenolanib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03620318|
Expanded Access Status : Available
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
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)
|Condition or disease||Intervention/treatment|
|FLT3-ITD Mutation FLT3/TKD Mutation PDGFR-Alpha D842V PDGFRA Gene Amplification||Drug: Crenolanib besylate|
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.
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620318
|Contact: Vinay Jain, MD||214-593-0500||Expanded.firstname.lastname@example.org|
|Ospedale Policlinico San Martino|
|Contact: Emanuele Angelucci, MD|