MedPath

Ponatinib

Generic Name
Ponatinib
Brand Names
Iclusig
Drug Type
Small Molecule
Chemical Formula
C29H27F3N6O
CAS Number
943319-70-8
Unique Ingredient Identifier
4340891KFS
Background

Ponatinib is a novel Bcr-Abl tyrosine kinase inhibitor that is especially effective against the T315I mutation for the treatment of chronic myeloid leukemia. FDA approved on December 14, 2012.

Indication

1.用于治疗达沙替尼或尼洛替尼治疗无效的慢性期、进展期或急性期的慢性粒细胞白血病(CML);或不能耐受达沙替尼或尼洛替尼者,以及临床不适合用伊马替尼进行后续治疗的患者;或T315I突变者。

2.用于治疗达沙替尼治疗无效的费城染色体阳性急性淋巴细胞白血病(Ph+ALL);或不能耐受达沙替尼者,以及临床不适合用伊马替尼进行后续治疗的患者;或T315I突变者。

Associated Conditions
Accelerated Phase Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukaemias (ALL), Chronic Phase Chronic Myeloid Leukemia, Blast phase Chronic myeloid leukemia
Associated Therapies
-

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses

Phase 2
Active, not recruiting
Conditions
Myeloid Leukemia, Chronic, Chronic Phase
Interventions
First Posted Date
2015-06-10
Last Posted Date
2025-01-08
Lead Sponsor
Takeda
Target Recruit Count
283
Registration Number
NCT02467270
Locations
🇦🇺

Royal Adelaide Hospital, Adelaide, South Australia, Australia

🇨🇦

Saskatchewan Cancer Agency, Regina, Saskatchewan, Canada

🇬🇧

Imperial College Healthcare NHS Trust, London, England, United Kingdom

and more 83 locations

Retrospective Evaluation of CML Patients in the National Compassionate Program

Terminated
Conditions
Chronic Myeloid Leukemia
Philadelphia Positive
Interventions
First Posted Date
2015-05-19
Last Posted Date
2022-10-26
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
38
Registration Number
NCT02448095
Locations
🇮🇹

ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE, Lecce, Italy

🇮🇹

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano, Milano, Italy

🇮🇹

Azienda Ospedaliera "S.Gerardo", Monza, Italy

and more 7 locations

Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib

Phase 2
Conditions
Chronic Myeloid Leukemia
Chronic Phase
Adults
Interventions
First Posted Date
2015-03-26
Last Posted Date
2022-01-05
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
16
Registration Number
NCT02398825
Locations
🇮🇹

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, Italy

🇮🇹

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi, Ancona, Italy

🇮🇹

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto", Catania, Italy

and more 34 locations

Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers

Phase 2
Completed
Conditions
Recurrent Non-small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Adenocarcinoma of the Lung
Stage IV Non-small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer
Limited Stage Small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Interventions
First Posted Date
2013-09-05
Last Posted Date
2022-02-11
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
171
Registration Number
NCT01935336
Locations
🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

Ponatinib in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma

Not Applicable
Withdrawn
Conditions
Endometrial Neoplasms
Interventions
First Posted Date
2013-06-27
Last Posted Date
2015-12-18
Lead Sponsor
Washington University School of Medicine
Registration Number
NCT01888562

A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

Phase 2
Completed
Conditions
GIST
Interventions
First Posted Date
2013-06-11
Last Posted Date
2018-05-18
Lead Sponsor
Ariad Pharmaceuticals
Target Recruit Count
45
Registration Number
NCT01874665
Locations
🇺🇸

Oregon Health & Sciences University, Site #048, Portland, Oregon, United States

🇺🇸

Fox Chase Cancer Center, Site #012, Philadelphia, Pennsylvania, United States

🇺🇸

Massachusetts General Hospital, Site #047, Boston, Massachusetts, United States

and more 1 locations

Ponatinib for Advanced Medullary Thyroid Cancer

Phase 2
Terminated
Conditions
Thyroid Neoplasms
Interventions
First Posted Date
2013-04-24
Last Posted Date
2017-02-15
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
3
Registration Number
NCT01838642
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Ponatinib in Advanced NSCLC w/ RET Translocations

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2013-03-19
Last Posted Date
2019-12-24
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
9
Registration Number
NCT01813734
Locations
🇺🇸

University of Maryland, Baltimore, Maryland, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Karmanos Cancer Institute, Detroit, Michigan, United States

and more 2 locations

Ponatinib for Squamous Cell Lung and Head and Neck Cancers

Phase 2
Terminated
Conditions
Non-Small Cell Lung Cancer, Head and Neck Cancer
Interventions
First Posted Date
2013-01-07
Last Posted Date
2014-12-23
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
3
Registration Number
NCT01761747
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 1 locations

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

Phase 3
Terminated
Conditions
Chronic Myeloid Leukemia
Interventions
First Posted Date
2012-07-26
Last Posted Date
2014-11-17
Lead Sponsor
Ariad Pharmaceuticals
Target Recruit Count
307
Registration Number
NCT01650805
Locations
🇺🇸

US Oncology - Providence Health System, Site #167, Burbank, California, United States

🇺🇸

UCLA Department of Medicine, Site #027, Los Angeles, California, United States

🇺🇸

Seattle Cancer Care Alliance, Site #100, Seattle, Washington, United States

and more 167 locations
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