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PONATINIB for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)
This study is currently recruiting participants.
Verified on April 2011 by Ariad Pharmaceuticals


First Received on September 20, 2010. Last Updated on April 1, 2011 History of Changes
Sponsor: Ariad Pharmaceuticals
Information provided by: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01207440

Purpose
The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.


Condition Intervention Phase
Myeloid Leukemia, Chronic
Ph+ Acute Lymphoblastic Leukemia (ALL)
Drug: Ponatinib (AP24534)
Phase II



Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia


Resource links provided by NLM:


MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Leukemia
U.S. FDA Resources



Further study details as provided by Ariad Pharmaceuticals:


Primary Outcome Measures:
•Major cytogenetic response (MCyR) CP patients, and Major Hematologic Response (MaHR) AP/BP and Ph+ ALL patients [ Time Frame: up to 24 months after first dose ] [ Designated as safety issue: No ]
1.For CML patients in CP at study entry: major cytogenetic response (MCyR), defined as complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CP patients in CCyR are not eligible for this study.
2.For CML patients in AP at study entry: major hematologic response (MaHR), defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). AP patients in MaHR are not eligible for this study.
3.For CML patients in BP at study entry or Ph+ ALL patients: MaHR, consisting of CHR or NEL. BP and Ph+ ALL patients in MaHR are not eligible for this study.



Secondary Outcome Measures:
•Clinical response, molecular response, clinical outcomes and safety [ Time Frame: up to 24 months after first dose ] [ Designated as safety issue: No ]
1.For CML patients in CP:

1.Hematologic responses: CHR;
2.Cytogenetic responses: confirmed MCyR; and
3.Molecular responses: major molecular response (MMR).
2.For CML patients in AP or BP or Ph+ ALL patients:

1.Cytogenetic responses: CCyR, PCyR, confirmed MCyR; and
2.Molecular responses: MMR.
3.For all patients: time to response, duration of response, progression free survival, and overall survival.
4.For all patients: safety and tolerability.



Estimated Enrollment: 320
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CML: Experimental
Intervention: Drug: Ponatinib (AP24534) Drug: Ponatinib (AP24534)
45 mg tablet taken orally once daily
Other Name: AP24534


Detailed Description:
The preliminary analysis of the phase 1 clinical trial revealed evidence of clinical antitumor activity in patients with resistance to approved second-generation tyrosine kinase inhibitors (TKI), dasatinib and nilotinib, including patients with the T315I mutation of BCR-ABL. This study, taken together with the strong preclinical data that characterize ponatinib, provides the rationale for moving to a pivotal phase 2 trial of this agent in a population of patients with chronic myeloid leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) who are resistant or intolerant to prior TKI therapy and in those patients with the T315I mutation.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

•Previously treated with and developed resistance or intolerance to dasatinib or nilotinib, or developed the T3151 mutation after any TKI therapy including imatinib
•=18 years old
•ECOG performance status =2
•Normal pancreatic function
•QTcF interval =450 ms for males and =470 ms for females
•Adequate renal and hepatic function
•Minimum life expectancy of =3 months
•Provide written informed consent
•Negative pregnancy test and agree to use effective form of contraception (if applicable)
Exclusion Criteria:

•Received prior tyrosine kinase inhibitor (TKI) treatment within 7 days prior to receiving the first dose of ponatinib
•Received other therapies as follows:

1.For CML chronic phase (CP) and accelerated phase (AP) patients, received hydroxyurea or anagrelide within 24 hours prior to receiving the first dose of ponatinib; interferon, cytarabine, or immunotherapy within 14 days prior to first dose of ponitinib; or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.
2.For CML blast phase (BP) patients, received chemotherapy within 14 days prior to the first dose of ponatinib.
3.For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of ponatinib; or vincristine within 7 days prior to the first dose of ponatinib; or received other chemotherapy within 14 days prior to the first dose of ponatinib.
4.All patients are excluded if they have not recovered from adverse events except alopecia) resulting from any prior treatments administered.
•Taking medications that are known to be associated with torsades de pointes
•Previously treated with ponatinib
•Underwent stem cell transplant <60 days prior to receiving first dose of ponatinib
•Evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy
•Require concurrent treatment with immunosuppressive agents
•Have active Central Nervous System (CNS) disease
•Have significant or active cardiovascular disease
•Have a significant bleeding disorder unrelated to CML or Ph+ALL
•Have a history of pancreatitis or alcohol abuse
•Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
•Underwent major surgery within 14 days prior to first dose of ponatinib
•Have ongoing or active infection
•Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of ponatinib
•Diagnosed with another primary malignancy in the past 3 years
•Pregnant or lactating
•Suffer from any other condition or illness that would compromise safety
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207440

Contacts
Contact: Frank Haluska, MD PhD 617-494-0400 [e-mail]
Contact: Christopher Turner, MD 617-494-0400 [e-mail]

Hide Study Locations

Locations
United States, California
UCLA Ronald Reagan Medical Center, Site #027 Recruiting
Los Angeles, California, United States, 90095
Contact: Rose Malone [e-mail]
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute, Site #017 Recruiting
Tampa, Florida, United States, 33612
Contact: Yuraima Rodriguez [e-mail]
United States, Georgia
Emory Winship Cancer Institute, Site # 058 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Beverly Bryan [e-mail]
United States, Illinois
The University of Chicago, Site # 001 Recruiting
Chicago, Illinois, United States, 60637
Contact: Howard Weiner [e-mail]
Northwestern University Feinberg School of Medicine, Site # 023 Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary Beth Riley [e-mail]
United States, Maryland
University of Maryland, Greenebaum Cancer Center, Site # 040 Recruiting
Baltimore, Maryland, United States, 21201
Contact: Curt Milnes [e-mail]
United States, Massachusetts
Dana-Farber Cancer Institute , Site # 008 Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kate Woodard [e-mail]
United States, Michigan
University of Michigan Medical Center, Site # 011 Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tina Willbee [e-mail]
Karmanos Cancer Institute, Site # 034 Recruiting
Detroit, Michigan, United States, 48201
Contact: Carmen Hughes [e-mail]
United States, Missouri
Washington University School of Medicine, Site # 007 Recruiting
St. Louis, Missouri, United States, 63110-1093
Contact: Marcus Grillot [e-mail]
United States, Nebraska
Nebraska Hematology-Oncology, PC, Site #133 Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Ashley Waldre [e-mail]
United States, New York
Roswell Park Cancer Institute, Site #029 Recruiting
Buffalo, New York, United States, 14263
Contact: Wendy Walinski [e-mail]
Weill Medical College of Cornell University, Site #006 Recruiting
New York, New York, United States, 10065
Contact: Tania J. Curcio, RN, BSN, CCRC [e-mail]
United States, Oregon
Oregon Health and Sciences University, Site #048 Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Chelsea Kline [e-mail]
United States, Pennsylvania
Jeanes Hospital of Temple University Health System, Site # 127 Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Beth Giammaruti [e-mail]
United States, Texas
MD Anderson Cancer Center, Site # 005 Recruiting
Houston, Texas, United States, 77030
Contact: Jody Hiteshew [e-mail]
United States, Utah
Huntsman Cancer Institute at the University of Utah, Site #043 Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchinson Cancer Research Center, Site #100 Recruiting
Seattle, Washington, United States, 98109
Contact: Vivian Oehler, MD [e-mail]
Australia, Queensland
Princess Alexandra Hospital, Site #942 Recruiting
Woollongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital, Site #951 Recruiting
Adelaide, South Australia, Australia, 5000a
Canada, Ontario
University Health Network, Princess Margaret Hospital, Site # 083 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Lidia Casciaro [e-mail]
Canada, Quebec
Jewish General Hospital, Site #129 Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Sylvia Lauwagie [e-mail]
France
Institut Bergonie, Site 772 Recruiting
Bordeaux, France, 33076
CHU de Poitiers, Site #945 Recruiting
Poitiers cedex, France, 86021
Germany
Charite - Universitatsmedizin Berlin, Site #701 Recruiting
Berlin, Germany, 13353
Universitatsklinikum Jena, Site #946 Recruiting
Jena, Germany, 07747
Medizinische Fakultat Mannheim der Universitat Heidelberg, Site #947 Recruiting
Mannheim, Germany, 68169
Korea, Republic of
The Catholic University of Korea, Site #938 Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Mi-Ri Jang [e-mail]
Netherlands
VU University Medical Center, Site #948 Recruiting
Amsterdam,, Netherlands, 1081 HV
Contact: Prof. Dr. C.H. Polman, Prof. Dr.
Singapore
Singapore General Hospital, Site #939 Recruiting
Blk 6 Level 5, Singapore, 169608
Contact: Ms. Elaine Tan Hwee Kee [e-mail]
Spain
Hospital Universitario La Paz, Site #966 Recruiting
Madrid, Spain, 28046
Hospital Clinico Universitario de Valencia, Site #964 Recruiting
Valencia, Spain, 46010
Sweden
Skane University Hospital, Site #944 Recruiting
Lund, Sweden, 221 85
Karolinska University Hospital Solna, Site #763 Recruiting
Stockholm, Sweden, 171 76
Uppsala University Hospital, Site #945 Recruiting
Uppsala, Sweden, 751 85
United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHG Trust, Site #969 Recruiting
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Ariad Pharmaceuticals
More Information

No publications provided

Responsible Party: Ariad Pharmaceuticals, Inc. ( Frank G. Haluska, M.D., Ph.D., Chief Medical Officer, VP, Clinical Research and Development )
ClinicalTrials.gov Identifier: NCT01207440 History of Changes
Other Study ID Numbers: AP24534-10-201
Study First Received: September 20, 2010
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ariad Pharmaceuticals:
CML
ALL
PH
ponatinib
PACE
Ph+ ALL



Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes



ClinicalTrials.gov processed this record on April 06, 2011


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