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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. Identifier: NCT03620318
Expanded Access Status : Available
First Posted : August 8, 2018
Last Update Posted : May 22, 2020
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

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)

Condition or disease Intervention/treatment
FLT3-ITD Mutation FLT3/TKD Mutation PDGFR-Alpha D842V PDGFRA Gene Amplification Drug: Crenolanib besylate

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.

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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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options
  • Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug

Exclusion Criteria:

  • Subject is eligible for enrollment in an ongoing clinical trial
  • Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation

Information from the National Library of Medicine

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 identifier (NCT number): NCT03620318

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Contact: Vinay Jain, MD 214-593-0500

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Ospedale Policlinico San Martino Available
Genova, Italy
Contact: Emanuele Angelucci, MD         
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
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Responsible Party: Arog Pharmaceuticals, Inc. Identifier: NCT03620318    
Other Study ID Numbers: ARO-EAP
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Keywords provided by Arog Pharmaceuticals, Inc.:
Compassionate use
Additional relevant MeSH terms:
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Antineoplastic Agents