Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01207440
Registration number
NCT01207440
Ethics application status
Date submitted
20/09/2010
Date registered
23/09/2010
Titles & IDs
Public title
Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
Query!
Scientific title
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia
Query!
Secondary ID [1]
0
0
2010-020414-28
Query!
Secondary ID [2]
0
0
AP24534-10-201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PACE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia
0
0
Query!
Ph+ Acute Lymphoblastic Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ponatinib
Experimental: Cohort A: CP-CML R-I - CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Experimental: Cohort B: CP-CML with T315I Mutation - CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Experimental: Cohort C: Accelerated Phase (AP)-CML R-I - AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Experimental: Cohort D: AP-CML with T315I Mutation - AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Experimental: Cohort E: Blast Phase (BP)-CML/Ph+ ALL R-I - BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Experimental: Cohort F: BP-CML or Ph+ ALL with T315I Mutation - BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Experimental: Unassigned to Cohorts A-F - Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Treatment: Drugs: Ponatinib
Ponatinib tablets.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of CP-CML Participants With Major Cytogenetic Response (MCyR)
Query!
Assessment method [1]
0
0
MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
Query!
Timepoint [1]
0
0
Up to 12 months after initiation of study treatment
Query!
Primary outcome [2]
0
0
Percentage of AP-CML Participants With Major Hematologic Response (MaHR)
Query!
Assessment method [2]
0
0
MaHR is defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). Response criteria for CHR is reported as white blood cells (WBC)=institutional upper limit of normal, absolute neutrophil count (ANC)=1000/mm\^3, platelets=100,000/mm\^3, no blasts or promyelocytes in peripheral blood, BM blasts =5%, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, no extramedullary involvement; Response criteria for NEL is reported as WBC=institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts =5%, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm\^3=platelets\<100,000/mm\^3; (ii) 500/mm\^3=ANC\<1000/mm\^3.
Query!
Timepoint [2]
0
0
Up to 6 months after initiation of study treatment
Query!
Primary outcome [3]
0
0
Percentage of BP-CML/Ph+ ALL Participants With MaHR
Query!
Assessment method [3]
0
0
MaHR is defined as percentage of participants with CHR or NEL. Response criteria for CHR is reported as WBC=institutional upper limit of normal, ANC=1000/mm\^3, platelets =100,000/mm\^3, no blasts or promyelocytes in peripheral blood, BM blasts =5%, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, no extramedullary involvement; Response criteria for NEL is reported as WBC= institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts =5%, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm\^3 =platelets\<100,000/mm\^3; (ii) 500/mm\^3=ANC\<1000/mm\^3.
Query!
Timepoint [3]
0
0
Up to 6 months after initiation of study treatment
Query!
Secondary outcome [1]
0
0
Percentage of CP-CML Participants With CHR
Query!
Assessment method [1]
0
0
Response criteria for CHR is reported as WBC=institutional upper limit of normal, platelets\<450,000/mm\^3, no blasts or promyelocytes in peripheral blood, \<5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood \<5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).
Query!
Timepoint [1]
0
0
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
Query!
Secondary outcome [2]
0
0
Percentage of CP-CML Participants With Confirmed MCyR
Query!
Assessment method [2]
0
0
Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart. For CP participants entering the trial in PCyR, confirmed MCyR is defined as 2 assessments of CCyR at least 28 days apart.
Query!
Timepoint [2]
0
0
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
Query!
Secondary outcome [3]
0
0
Percentage of CP-CML Participants With Major Molecular Response (MMR)
Query!
Assessment method [3]
0
0
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL =0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Query!
Timepoint [3]
0
0
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
Query!
Secondary outcome [4]
0
0
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MCyR
Query!
Assessment method [4]
0
0
MCyR is defined as percentage of participants with CCyR or PCyR. Cytogenetic response is the percentage of Ph+ metaphases in BM. Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
Query!
Timepoint [4]
0
0
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
Query!
Secondary outcome [5]
0
0
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With Confirmed MCyR
Query!
Assessment method [5]
0
0
Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart.
Query!
Timepoint [5]
0
0
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
Query!
Secondary outcome [6]
0
0
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MMR
Query!
Assessment method [6]
0
0
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL =0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Query!
Timepoint [6]
0
0
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
Query!
Secondary outcome [7]
0
0
Time to Response
Query!
Assessment method [7]
0
0
Time to response is defined as the interval from the first dose of study treatment until the criteria for response are first met, censored at the last assessment of response. Median time to response was estimated using the Kaplan-Meier method.
Query!
Timepoint [7]
0
0
Up to approximately 48 months after first dose
Query!
Secondary outcome [8]
0
0
Duration of Response
Query!
Assessment method [8]
0
0
Duration of Response is defined as the interval between the first assessment at which the criteria for response are met until the criteria for progression are met, censored at the last date at which the criteria for response are met. Duration of response was estimated by the Kaplan-Meier method as the probability of remaining in response.
Query!
Timepoint [8]
0
0
Up to approximately 48 months after first dose
Query!
Secondary outcome [9]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [9]
0
0
PFS is defined as the interval from the first dose of study treatment until the criteria for progression or death are met, censored at the last response assessment. Progression from CP is reported as death, development of AP or BP, loss of CHR (in the absence of cytogenetic response), confirmed by development in complete blood counts (CBCs) at least 4 weeks apart, loss of MCyR, increasing WBC in participant without CHR defined by doubling of WBC to \>20K on 2 occasions at least 4 weeks apart; Progression from AP is reported as death, development of confirmed BP, loss of previous major or minor hematologic response over a 2-week period, no decrease from baseline levels in percentage blasts in peripheral blood or BM on all assessments over a 4-week period; Progression from BP or Ph+ ALL is reported as death, increasing blasts in peripheral blood or BM over a 4 week period.
Query!
Timepoint [9]
0
0
Every 12 weeks ± 2 weeks from last dose of study drug or the investigator/participant decision to discontinue treatment, whichever occurred later (Up to approximately 96 months after last dose)
Query!
Secondary outcome [10]
0
0
Overall Survival (OS)
Query!
Assessment method [10]
0
0
OS is defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive.
Query!
Timepoint [10]
0
0
From the first dose of study treatment until death (Up to 96 months post last dose)
Query!
Secondary outcome [11]
0
0
Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Serious AE (SAE)
Query!
Assessment method [11]
0
0
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
Query!
Timepoint [11]
0
0
From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months)
Query!
Eligibility
Key inclusion criteria
* Participants must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL
* Previously treated with and developed resistance or intolerance to dasatinib or nilotinib OR developed the T3151 mutation after any tyrosine kinase inhibitor (TKI) therapy
* =18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status = 2
* Minimum life expectancy of =3 months
* Adequate kidney function
* Adequate liver function
* Normal pancreatic function
* Normal QT Fridericia-corrected interval (QTcF) =450 ms for males and =470 ms for females
* Negative pregnancy test (if woman of childbearing potential)
* Agree to use effective form of contraception (as applicable)
* Ability to comply with study procedures, in the Investigator's opinion
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Received prior TKI treatment within 7 days prior to receiving the first dose of ponatinib, or have not recovered from adverse events (except alopecia) due to agents previously administered.
* Received other therapies as follows:
1. For CML chronic phase (CP) and accelerated phase (AP) participants, 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 ponatinib; 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) participants, received chemotherapy within 14 days prior to the first dose of ponatinib.
3. For Ph+ ALL participants, 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.
* 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
* Taking medications that are known to be associated with Torsades de Pointes
* Require concurrent treatment with immunosuppressive agents (other than corticosteroids prescribed for a short course of therapy)
* Previously treated with ponatinib
* CML CP participants are excluded if they are in Complete cytogenetic response (CCyR)
* Participants with CML AP, CML BP, or Ph+ ALL are excluded if they are in Major Hematologic Response (MaHR).
* 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)
* 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
* Underwent major surgery within 14 days prior to first dose of ponatinib
* Have ongoing or active infection
* Suffer from any other condition or illness that would compromise safety or interfere with evaluation of the drug
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/09/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/01/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
449
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [4]
0
0
Alfred Hospital - Box Hill
Query!
Recruitment hospital [5]
0
0
Peter MacCallum Cancer Centre - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Bruxelles
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Leuven
Query!
Country [3]
0
0
France
Query!
State/province [3]
0
0
Bordeaux
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Le Chesnay
Query!
Country [5]
0
0
France
Query!
State/province [5]
0
0
Lille
Query!
Country [6]
0
0
France
Query!
State/province [6]
0
0
Nancy
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Nice
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Paris
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Pierre-Benite
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Poitiers
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Toulouse
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Berlin
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Frankfurt
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Jena
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Mannheim
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Munchen
Query!
Country [17]
0
0
Italy
Query!
State/province [17]
0
0
Bologna
Query!
Country [18]
0
0
Italy
Query!
State/province [18]
0
0
Modena
Query!
Country [19]
0
0
Italy
Query!
State/province [19]
0
0
Monza
Query!
Country [20]
0
0
Italy
Query!
State/province [20]
0
0
Orbassano (TO)
Query!
Country [21]
0
0
Italy
Query!
State/province [21]
0
0
Roma
Query!
Country [22]
0
0
Korea, Republic of
Query!
State/province [22]
0
0
Seoul
Query!
Country [23]
0
0
Netherlands
Query!
State/province [23]
0
0
Amsterdam
Query!
Country [24]
0
0
Netherlands
Query!
State/province [24]
0
0
Groningen
Query!
Country [25]
0
0
Singapore
Query!
State/province [25]
0
0
Singapore
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
Barcelona
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Madrid
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Salamanca
Query!
Country [29]
0
0
Spain
Query!
State/province [29]
0
0
Valencia
Query!
Country [30]
0
0
Sweden
Query!
State/province [30]
0
0
Lund
Query!
Country [31]
0
0
Sweden
Query!
State/province [31]
0
0
Stockholm
Query!
Country [32]
0
0
Sweden
Query!
State/province [32]
0
0
Uppsala
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Glasgow
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Liverpool
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
London
Query!
Country [36]
0
0
United Kingdom
Query!
State/province [36]
0
0
Newcastle
Query!
Country [37]
0
0
United Kingdom
Query!
State/province [37]
0
0
Nottingham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Ariad Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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 philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01207440
Query!
Trial related presentations / publications
Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Shah NP, Kantarjian HM. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018 Jul 26;132(4):393-404. doi: 10.1182/blood-2016-09-739086. Epub 2018 Mar 22. Januzzi JL, Garasic JM, Kasner SE, McDonald V, Petrie MC, Seltzer J, Mauro M, Croce K, Berman E, Deininger M, Hochhaus A, Pinilla-Ibarz J, Nicolini F, Kim DW, DeAngelo DJ, Kantarjian H, Xu J, Hall T, Srivastava S, Naranjo D, Cortes J. Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee. J Hematol Oncol. 2022 Jan 6;15(1):1. doi: 10.1186/s13045-021-01221-z. Erratum In: J Hematol Oncol. 2022 Mar 23;15(1):33. doi: 10.1186/s13045-022-01239-x. Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96. doi: 10.1056/NEJMoa1306494. Epub 2013 Nov 1. O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Erratum In: Nat Rev Cancer. 2012 Dec;12(12):886.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director Clinical Science
Query!
Address
0
0
Takeda
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/40/NCT01207440/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/40/NCT01207440/Prot_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, ...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT01207440