Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate bosutinib in Philadelphia chromosome-positive chronic myelogenous leukemia across chronic, accelerated, and blastic phases, solid tumors such as metastatic breast cancer and non-small-cell lung carcinoma, and neurodegenerative diseases including dementia with Lewy bodies. Sponsored by both pharmaceutical corporations and academic organizations, these investigations encompass various recruitment statuses—including active, recruiting, completed, terminated, and withdrawn—alongside bioequivalence studies in healthy participants.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04877522 RECRUITING
Chronic Myelogenous Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Novartis Pharmaceuticals
 2022-08-30 PHASE4
NCT04626024 ACTIVE_NOT_RECRUITING
Chronic Myeloid Leukemia; Chronic Myeloid Leukemia, BCR/ABL-Positive, in Remission; Chronic Myeloid Leukemia in Remission
Baylor College of Medicine
 2020-12-22 PHASE2
NCT04258943 ACTIVE_NOT_RECRUITING
Philadelphia Chromosome Positive CML; Accelerated Phase Chronic Myelogenous Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Chronic Phase Chronic Myelogenous Leukemia
Children's Oncology Group
 2020-07-06 PHASE1; PHASE2
NCT03297606 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
Canadian Cancer Trials Group
 2018-03-23 PHASE2
NCT06423911 RECRUITING
Chronic Myeloid Leukemia; CML; CML, Chronic Phase
Ascentage Pharma Group Inc.
 2024-02-05 PHASE3
NCT04578847 UNKNOWN
Chronic Myeloid Leukemia; Chronic Myeloid Leukemia in Remission; BCR-ABL Positive Chronic Myelogenous Leukemia
National Research Center for Hematology, Russia
 2020-01-15 PHASE2
NCT03831776 COMPLETED
Chronic Myeloid Leukemia
St. Olavs Hospital
 2019-03-25 PHASE2
NCT04709731 UNKNOWN
Chronic Myeloid Leukemia (CML)
Associazione Italiana Pazienti Leucemia Mieloide Cronica
 2021-02-01 PHASE2
NCT03654768 ACTIVE_NOT_RECRUITING
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
SWOG Cancer Research Network
 2018-10-24 PHASE2
NCT04744532 COMPLETED
Amyotrophic Lateral Sclerosis
Kyoto University
 2019-03-19 PHASE1; PHASE2
NCT02921477 UNKNOWN
Mild Cognitive Impairment; Dementia
Neurological Associates of West Los Angeles
 2016-09 PHASE1
NCT04655391 WITHDRAWN
Recurrent Acute Myeloid Leukemia
City of Hope Medical Center
 2022-06-25 PHASE1
NCT04971226 ACTIVE_NOT_RECRUITING
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
Novartis Pharmaceuticals
 2021-10-06 PHASE3
NCT03854903 COMPLETED
Metastatic Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Hormone Receptor Positive Breast Cancer
Georgetown University
 2019-04-01 PHASE1
NCT05032690 COMPLETED
Healthy Participants
Pfizer
 2022-01-19 PHASE1
NCT03023319 COMPLETED
Carcinoma, Non-Small-Cell Lung; Mesothelioma; Bladder Cancer; Ovarian Cancer; Peritoneal Cancer; Thymoma; Thymus Cancer; Uterine Cervical Cancer
Nagla Abdel Karim
 2019-12-10 PHASE1
NCT02311998 COMPLETED
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Blasts More Than 5 Percent of Bone Marrow Nucleated Cells; CD22 Positive; Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
M.D. Anderson Cancer Center
 2015-04-16 PHASE1; PHASE2
NCT04916769 COMPLETED
Healthy Participants
Pfizer
 2021-08-13 PHASE1
NCT05363488 Completed
Myeloid Leukemia
Pfizer
 2021-10-08 --
NCT04793399 TERMINATED
Chronic Phase-Chronic Myeloid Leukemia
Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica
 2021-02-24 PHASE1; PHASE2
NCT03888222 COMPLETED
Dementia With Lewy Bodies
Georgetown University
 2019-04-23 PHASE2
NCT02269267 COMPLETED
Leukemia, Myeloid, Chronic
Medical College of Wisconsin
 2014-12-18 PHASE2
NCT04549480 COMPLETED
Healthy Participants
Pfizer
 2020-09-16 PHASE1
NCT02228382 TERMINATED
Previously Treated PH + CML
Pfizer
 2014-11-07 PHASE4
NCT01903733 COMPLETED
Chronic Myeloid Leukemia
Pfizer
 2013-08-28
NCT03106779 COMPLETED
Chronic Myelogenous Leukemia
Novartis Pharmaceuticals
 2017-10-26 PHASE3
NCT02810990 COMPLETED
Chronic Myeloid Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
 2016-11-17 PHASE2
NCT04258943 Active not recruiting
Philadelphia Chromosome Positive CML|Accelerated Phase Chronic Myelogenous Leukemia|Blastic Phase Chronic Myelogenous Leukemia|Chronic Phase Chronic Myelogenous Leukemia
Children''s Oncology Group|Erasmus Medical Center|Dutch Childhood Oncology Group|Innovative Therapies for Children with Cancer|Pfizer
 2020-04-06 Phase 1|Phase 2
NCT03023319 Completed
Carcinoma Non-Small-Cell Lung|Mesothelioma|Bladder Cancer|Ovarian Cancer|Peritoneal Cancer|Thymoma|Thymus Cancer|Uterine Cervical Cancer
Nagla Abdel Karim|Augusta University
 2019-12-10 Phase 1
NCT02782403 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia (CML); Blast Phase Chronic Myelogenous Leukemia (CML); Chronic Phase Phase Chronic Myelogenous Leukemia (CML); Philadelphia Chromosome Positive (Ph+) Phase Chronic Myelogenous Leukemia (CML)
M.D. Anderson Cancer Center
 2017-03-20 PHASE1
NCT03205267 UNKNOWN
Chronic Myelogenous Leukaemia
University of Bonn
 2016-03 PHASE2
NCT02906696 TERMINATED
Blasts Under 15 Percent of Bone Marrow Nucleated Cells; Blasts Under 15 Percent of Peripheral Blood White Cells; Blasts Under 30 Percent of Bone Marrow Nucleated Cells; Blasts Under 30 Percent of Peripheral Blood White Cells; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
M.D. Anderson Cancer Center
 2016-10-28 PHASE2
NCT03888222 Completed
Dementia With Lewy Bodies
Georgetown University|Alzheimer''s Association
 2019-04-23 Phase 2
NCT03854903 Active not recruiting
Metastatic Breast Cancer|Human Epidermal Growth Factor 2 Negative Carcinoma of Breast|Hormone Receptor Positive Breast Cancer
Georgetown University|Pfizer
 2019-04-01 Phase 1
NCT03128411 COMPLETED
Leukemia, Chronic Myelogenous
Pfizer
 2017-05-15 PHASE2
NCT03747679 COMPLETED
CML
Pfizer
 2018-11-22 PHASE1
NCT02445742 COMPLETED
Chronic Myeloblastic Leukaemia
PETHEMA Foundation
 2015-05 PHASE2
NCT02638467 COMPLETED
Leukemia; Myelogenous; Chronic; BCR-ABL Positive
University of Milano Bicocca
 2015-11 PHASE2
NCT02130557 COMPLETED
Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Pfizer
 2014-07-15 PHASE3
NCT01331291 COMPLETED
Glioblastoma
Massachusetts General Hospital
 2011-04 PHASE2
NCT02192294 COMPLETED
Healthy
Pfizer
 2014-08 PHASE1
NCT01233869 COMPLETED
Polycystic Kidney, Autosomal Dominant
Pfizer
 2010-12 PHASE2
NCT02102633 COMPLETED
Healthy
Pfizer
 2014-05 PHASE1
NCT02058277 COMPLETED
Healthy
Pfizer
 2014-05 PHASE1
NCT00811070 COMPLETED
Chronic Myelogenous Leukemia
Pfizer
 2007-12 PHASE2
NCT01233882 COMPLETED
Renal Disease, End-Stage; Renal Insufficiency, Chronic; Renal Insufficiency, Acute
Pfizer
 2010-12 PHASE1
NCT01025570 TERMINATED
Pancreatic Cancer
University of California, San Francisco
 2010-05 PHASE1
NCT01374139 COMPLETED
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Pfizer
 2011-08 PHASE1
NCT00959946 TERMINATED
Advanced Breast Cancer (Parts 1 and 2); Advanced Pancreatic Cancer (Part 1); Advanced Colorectal Cancer (Part 1); Advanced Cholangiocarcinoma (Part 1); Advanced Glioblastoma Multiforme (Part 1)
Pfizer
 2009-09 PHASE1; PHASE2
NCT00574873 COMPLETED
Chronic Myeloid Leukemia
Pfizer
 2008-02-05 PHASE3
NCT00793546 TERMINATED
Advanced Breast Cancer
Pfizer
 2009-02 PHASE2
NCT00880009 TERMINATED
Breast Cancer
Pfizer
 2009-07-30 PHASE2
NCT01080365 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2010-02 PHASE1
NCT00952913 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2009-08 PHASE1
NCT00261846 COMPLETED
Chronic Myeloid Leukemia
Pfizer
 2006-01-18 PHASE2
NCT00934674 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2009-07 PHASE1
NCT00914121 COMPLETED
Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer
 2009-06 PHASE1
NCT00759837 COMPLETED
Breast Cancer; Leukemia, Myeloid, Chronic
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-10 PHASE1
NCT00319254 COMPLETED
Breast Neoplasms; Neoplasm Metastasis
Pfizer
 2006-05 PHASE2
NCT00757341 COMPLETED
Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-12 PHASE1
NCT00721474 COMPLETED
Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-09 PHASE1
NCT00725426 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-07 PHASE1
NCT00777530 COMPLETED
Breast Cancer; Tumors; Leukemia
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-04 PHASE1
NCT00195260 COMPLETED
Neoplasms
Pfizer
 2004-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-06)

Check the SKI-606 (Bosutinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bosutinib acts as a dual Src/Abl tyrosine kinase inhibitor that blocks the phosphorylation of p-ERK, p-S6, and p-STAT3, thereby downregulating downstream PI3K/AKT/mTOR, MAPK/ERK, and JAK/STAT3 signaling pathways. This molecular inhibition promotes autophagy and impairs cell proliferation, motility, and invasion, providing therapeutic rationale for treating chronic myelogenous leukemia and metastatic breast cancer.

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.