Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 3 evaluate crenolanib across diverse oncology indications, primarily targeting newly diagnosed or relapsed/refractory FLT3-mutated acute myeloid leukemia (AML), D842-mutant gastrointestinal stromal tumors (GIST), advanced solid tumors, and pediatric malignancies. Sponsored by pharmaceutical entities and academic institutions, these protocols exhibit variable recruitment statuses, including completed, available, terminated, and withdrawn. Key evaluations encompass Phase 2 GIST studies and randomized Phase 3 trials assessing crenolanib combined with chemotherapy for AML.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03258931 COMPLETED
Newly Diagnosed FLT3 Mutated AML
Arog Pharmaceuticals, Inc.
 2018-08-15 PHASE3
NCT03250338 COMPLETED
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Arog Pharmaceuticals, Inc.
 2018-08-16 PHASE3
NCT02400255 COMPLETED
Acute Myeloid Leukemia
Arog Pharmaceuticals, Inc.
 2015-09 PHASE2
NCT02847429 UNKNOWN
GIST With D842V Mutated PDGFRA Gene
Arog Pharmaceuticals, Inc.
 2016-08 PHASE3
NCT03324243 WITHDRAWN
Relapsed/Refractory FLT3-mutated AML
Arog Pharmaceuticals, Inc.
 2018-01 PHASE2
NCT03193918 COMPLETED
Esophagogastric Adenocarcinoma
Arog Pharmaceuticals, Inc.
 2017-04-14 PHASE1
NCT02400281 COMPLETED
Acute Myeloid Leukemia
Arog Pharmaceuticals, Inc.
 2015-09 PHASE1; PHASE2
NCT02626364 COMPLETED
Recurrent/Refractory Glioblastoma
Arog Pharmaceuticals, Inc.
 2016-04 PHASE2
NCT02298166 TERMINATED
Acute Myeloid Leukemia
University of Ulm
 2016-11-17 PHASE3
NCT02283177 COMPLETED
Newly Diagnosed AML With FLT3 Activating Mutations
Arog Pharmaceuticals, Inc.
 2015-01 PHASE2
NCT01657682 COMPLETED
Acute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior Therapies
Arog Pharmaceuticals, Inc.
 2012-10 PHASE2
NCT02626338 COMPLETED
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Arog Pharmaceuticals, Inc.
 2016-02 PHASE1; PHASE2
NCT02270788 COMPLETED
Acute Myeloid Leukemia
St. Jude Children's Research Hospital
 2015-04-02 PHASE1
NCT01393912 COMPLETED
Diffuse Intrinsic Pontine Glioma; Progressive or Refractory High-Grade Glioma
St. Jude Children's Research Hospital
 2011-07 PHASE1
NCT01522469 COMPLETED
Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Arog Pharmaceuticals, Inc.
 2012-07 PHASE2
NCT01243346 COMPLETED
D842-related Mutant GIST
Arog Pharmaceuticals, Inc.
 2011-04 PHASE2
NCT01229644 TERMINATED
Glioma
Arog Pharmaceuticals, Inc.
 2011-04 PHASE2
NCT00949624 Completed
Advanced Solid Tumors
Arog Pharmaceuticals Inc.
 2005-12 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-04-09)

Check the Crenolanib (CP-868596) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Crenolanib selectively binds to platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and FLT3—including the resistant PDGFRα D842V mutant—preventing receptor phosphorylation and blocking downstream signal transduction pathways. This receptor inhibition suppresses tumor cell proliferation, blocks angiogenesis, and promotes mitophagy, providing therapeutic anti-tumor activity in clinical trial conditions such as FLT3-mutated acute myeloid leukemia and mutant gastrointestinal stromal tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.