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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
-
Clinical Trials
Related News

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1
Terminated
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma
Interventions
Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat
First Posted Date
2019-03-18
Last Posted Date
2024-03-04
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT03878524
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Ponatinib in Advanced or Metastatic Medullary Thyroid Cancer

Phase 2
Withdrawn
Conditions
Medullary Thyroid Cancer
Interventions
Drug: Ponatinib
First Posted Date
2019-02-12
Last Posted Date
2021-10-13
Lead Sponsor
Antonio Fojo
Registration Number
NCT03838692

Study in Patients With Chronic Leukemia

Phase 2
Terminated
Conditions
Leukemia, Myeloid, Chronic-Phase
Interventions
Drug: Ponatinib
First Posted Date
2019-01-17
Last Posted Date
2023-09-14
Lead Sponsor
GWT-TUD GmbH
Target Recruit Count
18
Registration Number
NCT03807479
Locations
🇩🇪

University Hospital, Halle (Saale), Saxony-Anhalt, Germany

🇩🇪

University Hospital RWTH Aachen,Clinic for Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Department IV, Aachen, Germany

🇩🇪

Asklepios Clinic St. Georg - Department of Oncology, Section Hematology, Hamburg, Germany

and more 7 locations

Iclusig PMS in CML or Ph+ALL Patients

Active, not recruiting
Conditions
Chronic Myeloid Leukemia
Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
First Posted Date
2018-10-17
Last Posted Date
2022-12-07
Lead Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
50
Registration Number
NCT03709017
Locations
🇰🇷

Kosin University Gaspel Hospital, Busan, Korea, Republic of

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

Phase 3
Active, not recruiting
Conditions
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Interventions
Drug: Ponatinib
Drug: Imatinib
Drug: Vincristine
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate
Drug: Prednisone
First Posted Date
2018-07-17
Last Posted Date
2024-10-31
Lead Sponsor
Takeda
Target Recruit Count
245
Registration Number
NCT03589326
Locations
🇺🇸

Augusta University Georgia Cancer Center, Augusta, Georgia, United States

🇨🇦

Hopital Charles-LeMoyne, Greenfield Park, Quebec, Canada

🇧🇬

University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia, Sofiya, Bulgaria

and more 89 locations

Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive
BCR-ABL1 Fusion Protein Expression
Refractory Acute Lymphoblastic Leukemia
t(9;22)
Interventions
Biological: Blinatumomab
Drug: Cytarabine
Drug: Methotrexate
Drug: Ponatinib
First Posted Date
2017-08-28
Last Posted Date
2024-12-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
90
Registration Number
NCT03263572
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia

Phase 2
Active, not recruiting
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia with BCR-ABL1
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia
Interventions
Biological: Blinatumomab
Drug: Cyclophosphamide
Drug: Cytarabine
Biological: Filgrastim
Drug: Methotrexate
Biological: Pegfilgrastim
Drug: Ponatinib
Biological: Rituximab
Drug: Vincristine
First Posted Date
2017-05-10
Last Posted Date
2024-03-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT03147612
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Dose-Escalation Study of Ponatinib, a FLT3 Inhibitor, With and Without Combination of 5-Azacytidine, in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML)

Phase 1
Withdrawn
Conditions
Leukemia
FLT3-Mutated High-Risk Myelodysplastic Syndrome
FLT3-Mutated Acute Myeloid Leukemia
Interventions
Drug: Ponatinib
Drug: 5-azacytidine
Behavioral: Phone Calls
First Posted Date
2016-07-12
Last Posted Date
2017-06-02
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT02829840

Ponatinib With Chemotherapy for Young Adults Ph Positive Acute Lymphoblastic Leukemia

Phase 2
Conditions
ALL
Interventions
Drug: Prednisone
Drug: Vincristine
Drug: Daunorubicin
Drug: Ponatinib
Drug: Mercaptopurine
Drug: Methotrexate
Drug: VP-16
Drug: TIT
Procedure: Autologous transplantation
Procedure: Allo transplantation
First Posted Date
2016-05-18
Last Posted Date
2022-02-18
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
30
Registration Number
NCT02776605
Locations
🇪🇸

Hospital Clinic, Barcelona, Spain

🇪🇸

Hospital Germans Trias i Pujol, Badalona, Spain

🇪🇸

Hospital 12 de Octubre, Madrid, Spain

and more 7 locations

Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma

Phase 2
Completed
Conditions
Glioblastoma
Interventions
Drug: Ponatinib
First Posted Date
2015-06-23
Last Posted Date
2018-07-24
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
17
Registration Number
NCT02478164
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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