NCT03620318

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)

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

First QC Date

August 2, 2018

Last Update Submit

August 7, 2024

Conditions

FLT3-ITD MutationFLT3/TKD MutationPDGFR-Alpha D842VPDGFRA Gene Amplification

Keywords

Compassionate use

Interventions

Crenolanib besylateDRUG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Policlinico San Martino

Genova, Italy

AVAILABLE

Central Study Contacts

Vinay Jain, MD

CONTACT

214-593-0500info@arogpharma.com

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 8, 2018

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

IT(1)