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

Primary Purpose

Chronic Myeloid Leukemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ponatinib
imatinib (Gleevec/ Glivec)
Sponsored by
Ariad Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. CP CML within 6 months of diagnosis

    • CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) ≥100 × 10^9/L platelets (≥100,000/mm^3); (v) No evidence of extramedullary disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML

  2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome

    • (a)Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques; (b) Conventional chromosome banding must be performed; AND (c) A minimum of 20 metaphases must be assessable at entry
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

  4. Adequate hepatic function as defined by the following criteria:

    (a) Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome; (b) Alanine aminotransferase (ALT) ≤2.5 × ULN; AND (c) Aspartate aminotransferase (AST) ≤2.5 × ULN

  5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
  6. Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN

Exclusion Criteria:

  1. Received prior imatinib therapy
  2. Received prior dasatinib therapy
  3. Received prior nilotinib therapy
  4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
  5. Major surgery within 28 days prior to initiating therapy
  6. History of bleeding disorder unrelated to CML
  7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
  8. History of alcohol abuse
  9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)

  10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:

    1. Myocardial infarction, within 6 months prior to randomization
    2. Unstable angina within 6 months prior to randomization
    3. Congestive heart failure within 6 months prior to randomization
    4. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
    5. Any history of ventricular arrhythmia
    6. Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization
    7. Any history of peripheral arterial occlusive disease requiring revascularization
    8. Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
  11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
  12. Taking medications that are known to be associated with Torsades de Pointes
  13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection
  14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history
  15. Pregnant or breastfeeding
  16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
  17. Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
  18. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug

Sites / Locations

  • US Oncology - Providence Health System, Site #167
  • UCLA Department of Medicine, Site #027
  • Bay Area Cancer Research Group, Site #156
  • Bay Area Cancer Research Group, Site #157
  • Rocky Mountain Cancer Centers, Site #191
  • Cancer Center of Central Connecticut, Site #147
  • Christiana Care Health Services, Site #155
  • University Cancer Institute, Site #149
  • Florida Cancer Specialists, Site #180
  • Florida Cancer Specialists, Site #179
  • Emory University, Site #058
  • John H. Stroger, Jr. Hospital of Cook County, Site #192
  • University of Chicago, Site #001
  • Loyola University Chicago, Site #054
  • Franciscan St. Francis Health, Site #138
  • University of Iowa Hospitals and Clinics, Site #050
  • Siouxland Hematology-Oncology Associates, Site #198
  • US Oncology - Cancer Center of Kansas, Site #168
  • Willis-Knighton Cancer Center, Site #196
  • University of Maryland, Greenebaum Cancer Center, Site #040
  • Greater Baltimore Medical Center, Site #140
  • St. Agnes Healthcare, Site #185
  • Massachusetts General Hospital, Site #047
  • Dana Farber Cancer Institute, Site #008
  • University of Massachusetts Worcester, Site #152
  • University of Michigan Medical Center, Site #011
  • Providence Cancer Institute, Site #197
  • Mayo Clinic, Site #044
  • Oncology Research Park Nicollet Institute, Site #195
  • Saint Luke's Hospital, Site #162
  • Mercy Clinic - Cancer & Hematology, Site #151
  • Nebraska Hematology-Oncology, P.C., Site # 133
  • US Oncology - Comprehensive Cancer Center of Nevada, Site #169
  • John Theurer Cancer Center, Site #128
  • University of New Mexico Cancer Center, Site #166
  • Maimonides Cancer Center, Site #177
  • Winthrop University Hospital, Site #153
  • Beth Israel Medical Center, Site #145
  • Mount Sinai School of Medicine, Site #189
  • Memorial Sloan-Kettering Cancer Center, Site #078
  • Weill Cornell Medical College, Site #006
  • New York Medical College, Site #146
  • Southeastern Medical Oncology Center, Site #188
  • Signal Point Clinical Research Center, Site #139
  • University of Oklahoma, Site #028
  • Providence Cancer Center Oncology and Hematology Care Eastside, Site #194
  • Kaiser Permanente Northwest, Site #200
  • Oregon Health & Science University, Site #048
  • Gettysburg Cancer Center, Site #160
  • Western Pennsylvania Hospital, Site #159
  • Medical University of South Carolina, Site #148
  • Carolina Hematology Oncology, Site #143
  • Associates in Oncology & Hematology, Site #186
  • Sarah Cannon Research Institute, Site #076
  • US Oncology - Texas Oncology Austin, Site #172
  • US Oncology - Texas Oncology Dallas, Site #171
  • University of Texas Southwestern Medical Center, Site #178
  • Baylor College of Medicine, Site #063
  • US Oncology - Texas Oncology Midland, Site #173
  • US Oncology - Cancer Care Center of South Texas, Site #170
  • Huntsman Cancer Institute, Site #043
  • VCU Massey Cancer Center, Dalton Oncology Clinic, Site #069
  • Seattle Cancer Care Alliance, Site #100
  • US Oncology - Northwest Cancer Specialists, Site #174
  • West Virginia University, Site #154
  • Green Bay Oncology, Ltd. / St. Mary's Hospital Medical Center, Site #193
  • University of Wisconsin, Site #030
  • Canberra Hospital, Site #971
  • Royal North Shore Hospital, Site #941
  • Royal Adelaide Hospital, Site #951
  • The Peter MacCallum Cancer Center, Site #950
  • Box Hill Hospital, Site #940
  • Royal Perth Hospital, Site #972
  • Medizinische Universitat Wien / AKH, Universitatsklinik fur Inniere Medizin I, Site #561
  • UZ Brussel - Department Hematology, Site #544
  • Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508
  • UZ Gent - Department Hematology, Site #756
  • UZ Gasthuisberg - Department of Hematology, Site #700
  • University Health Network, Princess Margaret Hospital, Site #083
  • Jewish General Hospital, Site #129
  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Site #514
  • FN Hradec Kralove, Site #517
  • Fakultni nemocnice Olomouc, Hematoonkologicka klinika, Site #515
  • Ustav hematologie a krevni transfuse, Site #516
  • Helsinki University Central Hospital, Site #542
  • Institut Bergonie, Site #772
  • CHRU de Brest, Hopital Morvan, Site #523
  • CHU Henri Mondor, Site #520
  • Centre Hospitalier de Versailles, Site #958
  • Hospital Claude Huriez, Site #952
  • Institut Paoli Calmette, Site #519
  • CHU de Brabois, Site #953
  • CHU de Nantes, Site #521
  • Service Hematologie - Hospital Archet I, Site #509
  • Hopital Saint-Louis, Site #957
  • Hospital Saint Antoine, Site #518
  • Centre Hospitalier Lyon Sud, Site #956
  • CHU de Poitiers, Site #954
  • CHU Purpan, Site #955
  • Universitätsklinikum Aachen, AÖR, Site #513
  • Charite - Universitatsmedizin Berlin, Site #701
  • Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526
  • Universitatsklinikum Freiburg, Site #527
  • Universitatsklinikum Hamburg-Eppendorf, Site #524
  • Universitatsklinikum Jena, Site #946
  • Universitatsklinikum Koln-AOR, Site #525
  • Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947
  • Klinikum rechts der Isar, Site #949
  • Prince of Wales Hospital, Site #974
  • Queen Mary Hospital, Site #973
  • Unita Operativa di Ematologia con Trapianto, Site #529
  • Istituto di Ematologia "L. & A. Seragnoli", Site #959
  • A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530
  • Clinica Ematologica, Site #528
  • Ospedale Niguarda Ca' Granda di Milano, Site #531
  • S.C. Ematologia, Site #960
  • San Gerardo Hospital, Site #961
  • U.O.C Ematologia con trapianto di midollo osseo, Site #560
  • Universita Federico II, Site #510
  • SCDU Medicina Interna II - Indirizzo Ematologico, Site #785
  • Dipartimento di Biotecnologie Cellulari ed Ematologia Universita La Sapienza - Policlinico Umberto I, Site #511
  • U.O. di Ematologia - Ospedale S. Eugenio, Site #962
  • The Catholic University of Korea, Site #938
  • VU Medical Centre - Department Haematology, Site #948
  • Auckland City Hospital, Site #921
  • Christchurch Hospital, Site #922
  • Waikato Hospital, Site #977
  • North Shore Hospital, Site #976
  • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Medyczne, Site #548
  • Malopolskie Centrum Medyczne, Site #546
  • Klinika Hematologii Wojewodzkiego Szpitala Specjalistycznego, Site #550
  • Oddzial Hematologii, Site #551
  • Katedra i Klinika Hematologii, Site #547
  • Instituto Portugues de Oncologia, Site #545
  • Fundacion de Investigacion de Diego, Site #199
  • Singapore General Hospital, Site #939
  • Narodny onkologicky ustav, Site #532
  • Univerzitna nemocnica Martin, Site #533
  • Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554
  • Hospital Universitari Germans Trias i Pujol, Site #512
  • Hospital Clinic, Site #963
  • Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734
  • Hospital Universitari Son Espases, Site #553
  • Hospital Universitario La Princesa, Site #555
  • Hospital Gregorio Maranon, Site #536
  • H.U. Ramon y Cajal, Site #538
  • Hospital Universitario 12 de Octubre, Site #537
  • Hospital La Paz, Site #966
  • Hospital Universitario Central de Asturias, Site #535
  • Hospital Universitario de Salamanca, Site #965
  • Hospital Clinico Universitario de Valencia, Site #964
  • Skane University Hospital, Site #944
  • Karolinska University Hospital Huddinge, Site #534
  • Karolinska University Hospital Solna, Site #763
  • Uppsala University Hospital, Site #945
  • Kantonsspital Aarau, Site #541
  • Kantonsspital St. Gallen, Site #707
  • Kaohsiung Chang Gung Memorial Hospital, Site #980
  • China Medical University Hospital, Site #978
  • National Taiwan University Hospital, Site #979
  • Western General Hospital, Site #556
  • Kent and Medway Cancer Research Network, Site #558
  • University of Glasgow, Site #797
  • St. James University Hospital, Site #540
  • Royal Liverpool University Hospital, Site #969
  • Hammersmith Hospital, Site #967
  • Newcastle University, Site #970
  • Norfolk & Norwich University Hospital Foundation Trust, Site #557
  • Nottingham University Hospitals NHS Trust, Site #968
  • Oxford University Hospitals NHS Trust, Site #543

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ponatinib

imatinib

Arm Description

Outcomes

Primary Outcome Measures

Major Molecular Response (MMR) Rate at 12 Months
A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.

Secondary Outcome Measures

MMR Rate
To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years
<10% BCR-ABL^IS Rate
To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib
Complete Cytogenetic Response (CCyR) Rate
The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.
Progression-free Survival
To compare, according to treatment with ponatinib versus imatinib, progression-free survival
Overall Survival
To compare, according to treatment with ponatinib versus imatinib, overall survival

Full Information

First Posted
July 18, 2012
Last Updated
November 5, 2014
Sponsor
Ariad Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01650805
Brief Title
Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
Official Title
A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Study terminated based on evaluation of safety data.
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ariad Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.
Detailed Description
This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib. Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis (low, intermediate, high), to receive once daily oral administration of either ponatinib or imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates at various timepoints; time to, duration of, and durability of responses; and survival follow-up. Safety measures include clinical laboratory testing, adverse event monitoring, vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status, and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is expected to take approximately 2 years, and patients will be followed for survival for up to 8 years after the last patient's first dose; therefore, patient participation may last up to 10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ponatinib
Arm Type
Experimental
Arm Title
imatinib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ponatinib
Intervention Description
45 mg tablet, taken orally once daily
Intervention Type
Drug
Intervention Name(s)
imatinib (Gleevec/ Glivec)
Intervention Description
400 mg tablet, taken orally once daily
Primary Outcome Measure Information:
Title
Major Molecular Response (MMR) Rate at 12 Months
Description
A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.
Time Frame
12 months after first dose
Secondary Outcome Measure Information:
Title
MMR Rate
Description
To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years
Time Frame
5 years after first dose
Title
<10% BCR-ABL^IS Rate
Description
To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib
Time Frame
3 months after first dose
Title
Complete Cytogenetic Response (CCyR) Rate
Description
The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.
Time Frame
12 months after first dose
Title
Progression-free Survival
Description
To compare, according to treatment with ponatinib versus imatinib, progression-free survival
Time Frame
Up to 8 years after the last patient's first dose
Title
Overall Survival
Description
To compare, according to treatment with ponatinib versus imatinib, overall survival
Time Frame
Up to 8 years after the last patient's first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CP CML within 6 months of diagnosis CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) ≥100 × 10^9/L platelets (≥100,000/mm^3); (v) No evidence of extramedullary disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome (a)Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques; (b) Conventional chromosome banding must be performed; AND (c) A minimum of 20 metaphases must be assessable at entry Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 Adequate hepatic function as defined by the following criteria: (a) Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome; (b) Alanine aminotransferase (ALT) ≤2.5 × ULN; AND (c) Aspartate aminotransferase (AST) ≤2.5 × ULN Adequate renal function as defined as defined by serum creatinine <1.5 x ULN Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN Exclusion Criteria: Received prior imatinib therapy Received prior dasatinib therapy Received prior nilotinib therapy Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea Major surgery within 28 days prior to initiating therapy History of bleeding disorder unrelated to CML History of acute pancreatitis within 1 year of study or history of chronic pancreatitis History of alcohol abuse Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL) Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: Myocardial infarction, within 6 months prior to randomization Unstable angina within 6 months prior to randomization Congestive heart failure within 6 months prior to randomization History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia Any history of ventricular arrhythmia Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization Any history of peripheral arterial occlusive disease requiring revascularization Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control Taking medications that are known to be associated with Torsades de Pointes Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history Pregnant or breastfeeding Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ) Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug
Facility Information:
Facility Name
US Oncology - Providence Health System, Site #167
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
UCLA Department of Medicine, Site #027
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Bay Area Cancer Research Group, Site #156
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Bay Area Cancer Research Group, Site #157
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Rocky Mountain Cancer Centers, Site #191
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Cancer Center of Central Connecticut, Site #147
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Christiana Care Health Services, Site #155
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University Cancer Institute, Site #149
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Florida Cancer Specialists, Site #180
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists, Site #179
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Emory University, Site #058
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County, Site #192
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago, Site #001
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Chicago, Site #054
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Franciscan St. Francis Health, Site #138
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Hospitals and Clinics, Site #050
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, Site #198
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
US Oncology - Cancer Center of Kansas, Site #168
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Willis-Knighton Cancer Center, Site #196
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Maryland, Greenebaum Cancer Center, Site #040
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Greater Baltimore Medical Center, Site #140
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
St. Agnes Healthcare, Site #185
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Massachusetts General Hospital, Site #047
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute, Site #008
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Worcester, Site #152
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Medical Center, Site #011
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Providence Cancer Institute, Site #197
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Mayo Clinic, Site #044
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Oncology Research Park Nicollet Institute, Site #195
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Saint Luke's Hospital, Site #162
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Clinic - Cancer & Hematology, Site #151
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Nebraska Hematology-Oncology, P.C., Site # 133
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
US Oncology - Comprehensive Cancer Center of Nevada, Site #169
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
John Theurer Cancer Center, Site #128
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico Cancer Center, Site #166
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Maimonides Cancer Center, Site #177
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Winthrop University Hospital, Site #153
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Beth Israel Medical Center, Site #145
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai School of Medicine, Site #189
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center, Site #078
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College, Site #006
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
New York Medical College, Site #146
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Southeastern Medical Oncology Center, Site #188
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Signal Point Clinical Research Center, Site #139
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
University of Oklahoma, Site #028
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Cancer Center Oncology and Hematology Care Eastside, Site #194
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente Northwest, Site #200
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University, Site #048
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Gettysburg Cancer Center, Site #160
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Western Pennsylvania Hospital, Site #159
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina, Site #148
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Carolina Hematology Oncology, Site #143
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Associates in Oncology & Hematology, Site #186
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Sarah Cannon Research Institute, Site #076
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
US Oncology - Texas Oncology Austin, Site #172
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
US Oncology - Texas Oncology Dallas, Site #171
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Southwestern Medical Center, Site #178
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine, Site #063
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
US Oncology - Texas Oncology Midland, Site #173
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Facility Name
US Oncology - Cancer Care Center of South Texas, Site #170
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Huntsman Cancer Institute, Site #043
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
VCU Massey Cancer Center, Dalton Oncology Clinic, Site #069
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Seattle Cancer Care Alliance, Site #100
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
US Oncology - Northwest Cancer Specialists, Site #174
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
West Virginia University, Site #154
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Green Bay Oncology, Ltd. / St. Mary's Hospital Medical Center, Site #193
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
University of Wisconsin, Site #030
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Canberra Hospital, Site #971
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal North Shore Hospital, Site #941
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Adelaide Hospital, Site #951
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Peter MacCallum Cancer Center, Site #950
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Box Hill Hospital, Site #940
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Perth Hospital, Site #972
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Medizinische Universitat Wien / AKH, Universitatsklinik fur Inniere Medizin I, Site #561
City
Wien
ZIP/Postal Code
01090
Country
Austria
Facility Name
UZ Brussel - Department Hematology, Site #544
City
Brussel
Country
Belgium
Facility Name
Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508
City
Bruxelles
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UZ Gent - Department Hematology, Site #756
City
Gent
Country
Belgium
Facility Name
UZ Gasthuisberg - Department of Hematology, Site #700
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Health Network, Princess Margaret Hospital, Site #083
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital, Site #129
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Site #514
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
FN Hradec Kralove, Site #517
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Fakultni nemocnice Olomouc, Hematoonkologicka klinika, Site #515
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Ustav hematologie a krevni transfuse, Site #516
City
Praha
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Helsinki University Central Hospital, Site #542
City
Helsinki
Country
Finland
Facility Name
Institut Bergonie, Site #772
City
Bordeaux
Country
France
Facility Name
CHRU de Brest, Hopital Morvan, Site #523
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Henri Mondor, Site #520
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier de Versailles, Site #958
City
Le Chesnay Cedex
Country
France
Facility Name
Hospital Claude Huriez, Site #952
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Paoli Calmette, Site #519
City
Marseille
Country
France
Facility Name
CHU de Brabois, Site #953
City
Nancy Cedex
Country
France
Facility Name
CHU de Nantes, Site #521
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Facility Name
Service Hematologie - Hospital Archet I, Site #509
City
Nice Cedex
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint-Louis, Site #957
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hospital Saint Antoine, Site #518
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon Sud, Site #956
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Poitiers, Site #954
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU Purpan, Site #955
City
Toulouse Cedex
Country
France
Facility Name
Universitätsklinikum Aachen, AÖR, Site #513
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin, Site #701
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Freiburg, Site #527
City
Freiburg
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf, Site #524
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Jena, Site #946
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitatsklinikum Koln-AOR, Site #525
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum rechts der Isar, Site #949
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Prince of Wales Hospital, Site #974
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital, Site #973
City
Hong Kong
Country
Hong Kong
Facility Name
Unita Operativa di Ematologia con Trapianto, Site #529
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto di Ematologia "L. & A. Seragnoli", Site #959
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Clinica Ematologica, Site #528
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Niguarda Ca' Granda di Milano, Site #531
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
S.C. Ematologia, Site #960
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
San Gerardo Hospital, Site #961
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
U.O.C Ematologia con trapianto di midollo osseo, Site #560
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita Federico II, Site #510
City
Napoli
Country
Italy
Facility Name
SCDU Medicina Interna II - Indirizzo Ematologico, Site #785
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Dipartimento di Biotecnologie Cellulari ed Ematologia Universita La Sapienza - Policlinico Umberto I, Site #511
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
U.O. di Ematologia - Ospedale S. Eugenio, Site #962
City
Rome
ZIP/Postal Code
144
Country
Italy
Facility Name
The Catholic University of Korea, Site #938
City
Seocho-gu
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
VU Medical Centre - Department Haematology, Site #948
City
Amsterdam
ZIP/Postal Code
1081-HV
Country
Netherlands
Facility Name
Auckland City Hospital, Site #921
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital, Site #922
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital, Site #977
City
Hamilton
Country
New Zealand
Facility Name
North Shore Hospital, Site #976
City
Takapuna
ZIP/Postal Code
0740
Country
New Zealand
Facility Name
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Medyczne, Site #548
City
Gdansk
Country
Poland
Facility Name
Malopolskie Centrum Medyczne, Site #546
City
Krakow
Country
Poland
Facility Name
Klinika Hematologii Wojewodzkiego Szpitala Specjalistycznego, Site #550
City
Lodz
Country
Poland
Facility Name
Oddzial Hematologii, Site #551
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Katedra i Klinika Hematologii, Site #547
City
Wroclaw
Country
Poland
Facility Name
Instituto Portugues de Oncologia, Site #545
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Fundacion de Investigacion de Diego, Site #199
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Singapore General Hospital, Site #939
City
Singapore
Country
Singapore
Facility Name
Narodny onkologicky ustav, Site #532
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin, Site #533
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol, Site #512
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic, Site #963
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitari Son Espases, Site #553
City
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Universitario La Princesa, Site #555
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Gregorio Maranon, Site #536
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H.U. Ramon y Cajal, Site #538
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre, Site #537
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz, Site #966
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Central de Asturias, Site #535
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Universitario de Salamanca, Site #965
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia, Site #964
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Skane University Hospital, Site #944
City
Lund
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge, Site #534
City
Stockholm
Country
Sweden
Facility Name
Karolinska University Hospital Solna, Site #763
City
Stockholm
Country
Sweden
Facility Name
Uppsala University Hospital, Site #945
City
Uppsala
Country
Sweden
Facility Name
Kantonsspital Aarau, Site #541
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Kantonsspital St. Gallen, Site #707
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kaohsiung Chang Gung Memorial Hospital, Site #980
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital, Site #978
City
Taiching
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital, Site #979
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Western General Hospital, Site #556
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Kent and Medway Cancer Research Network, Site #558
City
Gillingham
Country
United Kingdom
Facility Name
University of Glasgow, Site #797
City
Glasgow
ZIP/Postal Code
G120SB
Country
United Kingdom
Facility Name
St. James University Hospital, Site #540
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital, Site #969
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Hammersmith Hospital, Site #967
City
London
Country
United Kingdom
Facility Name
Newcastle University, Site #970
City
Newcastle
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital Foundation Trust, Site #557
City
Norwich
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust, Site #968
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust, Site #543
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34699069
Citation
Hanley MJ, Diderichsen PM, Narasimhan N, Srivastava S, Gupta N, Venkatakrishnan K. Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development. J Clin Pharmacol. 2022 Apr;62(4):555-567. doi: 10.1002/jcph.1990. Epub 2021 Dec 16.
Results Reference
derived
PubMed Identifier
27083332
Citation
Lipton JH, Chuah C, Guerci-Bresler A, Rosti G, Simpson D, Assouline S, Etienne G, Nicolini FE, le Coutre P, Clark RE, Stenke L, Andorsky D, Oehler V, Lustgarten S, Rivera VM, Clackson T, Haluska FG, Baccarani M, Cortes JE, Guilhot F, Hochhaus A, Hughes T, Kantarjian HM, Shah NP, Talpaz M, Deininger MW; EPIC investigators. Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2016 May;17(5):612-21. doi: 10.1016/S1470-2045(16)00080-2. Epub 2016 Apr 12.
Results Reference
derived

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

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