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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02467270




Registration number
NCT02467270
Ethics application status
Date submitted
2/06/2015
Date registered
10/06/2015
Date last updated
23/06/2020

Titles & IDs
Public title
Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
Scientific title
A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
Secondary ID [1] 0 0
2014-001617-12
Secondary ID [2] 0 0
AP24534-14-203
Universal Trial Number (UTN)
Trial acronym
OPTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloid Leukemia, Chronic, Chronic Phase 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ponatinib 45 mg
Treatment: Drugs - Ponatinib 30 mg
Treatment: Drugs - Ponatinib 15 mg

Experimental: Cohort A - Ponatinib 45 mg once daily starting dose.

Experimental: Cohort B - Ponatinib 30 mg once daily starting dose.

Experimental: Cohort C - Ponatinib 15 mg once daily starting dose.


Treatment: Drugs: Ponatinib 45 mg
45 mg tablet, taken orally once daily.

Treatment: Drugs: Ponatinib 30 mg
30 mg tablet, taken orally once daily.

Treatment: Drugs: Ponatinib 15 mg
15 mg tablet, taken orally once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with <=1% BCR-ABL1IS at Month 12
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Percentage of Participants With Major Molecular Response (MMR) at Months 12 and 24 - MMR is defined as percentage of participants with major molecular response.
Timepoint [1] 0 0
Months 12 and 24
Secondary outcome [2] 0 0
Major Cytogenetic Response (MCyR) Rates by Month 12 - 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: 0% Ph + metaphases; PCyR: greater than (>) 0 to 35% Ph + metaphases.
Timepoint [2] 0 0
Up to Month 12
Secondary outcome [3] 0 0
Duration of MMR - Duration of MMR is defined as the interval between the first assessment at which the criteria for <=1% MMR are met until the earliest date at which loss of <=1% MMR occurs, or the criteria for progression are met.
Timepoint [3] 0 0
Baseline up to Month 24
Secondary outcome [4] 0 0
Percentage of Participants with Adjusted Incidence Rates for Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs), Adverse Events (AEs), and Serious AEs (SAEs) - Percentage of participants with adjusted incidence rates who developed AOEs and VTEs will be categorized according to arterial occlusive events (Cardiac occlusive/thrombotic events, cerebral occlusive/thrombotic events and peripheral occlusive/thrombotic events) and venous thrombotic events.
Timepoint [4] 0 0
Baseline up to Month 24
Secondary outcome [5] 0 0
Percentage of Participants With CCyR at Month 12 - Cytogenetic response is the percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. CCyR is defined as 0% Ph+ metaphases.
Timepoint [5] 0 0
Month 12
Secondary outcome [6] 0 0
Percentage of Participants With Major Molecular Response (MMR), Molecular Response 4 (MR4) and Molecular Response (MR4.5) - MR4 is defined as <=0.01% BCR-ABL1IS. MR 4.5 is defined as <=0.0032% BCR-ALB1IS.
Timepoint [6] 0 0
Baseline up to Month 24
Secondary outcome [7] 0 0
Percentage of Participants With Molecular Response 1 (MR1) at Month 3 - MR1 is defined as percentage of participants achieving a ratio of <=10% Breakpoint Cluster Region-abelson (BCR-ABL1) transcripts on the international scale.
Timepoint [7] 0 0
Month 3
Secondary outcome [8] 0 0
Percentage of Participants With Complete hematologic Response (CHR) at Month 3 - CHR is defined as achieving all of the following measurements: white blood cells (WBC) <= institutional upper limit of normal (ULN), platelets less than (<) 450,000 per cubic millimeter (/mm^3), no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, and no extramedullary involvement (including no hepatomegaly or splenomegaly).
Timepoint [8] 0 0
Month 3
Secondary outcome [9] 0 0
Percentage of Participants with AEs Leading to Discontinuation and Dose Reduction
Timepoint [9] 0 0
Baseline up to Month 24
Secondary outcome [10] 0 0
Percentage of Participants with Dose Interruptions
Timepoint [10] 0 0
Baseline up to Month 24
Secondary outcome [11] 0 0
Duration of Response (DOR) of <=1% BCR-ABL1 IS - Duration of <=1% BCR-ABL1IS is defined as the interval between the first assessment at which the criteria for <=1% BCR-ABL1IS are met until the earliest date at which loss of <=1% BCR-ABL1IS occurs, or the criteria for progression (progression to accelerated phase [AP] or blast phase [BP] of CML) are met. Loss of <=1% BCR-ABL1IS is an increase to >1% of BCR-ABL1IS. Progression to AP is defined as: greater than or equal to (>=) 15% and <30% blasts in peripheral blood or bone marrow or >=20% basophils in peripheral blood or bone marrow or >=30% blasts + promyelocytes in peripheral blood or bone marrow (but <30% blasts) or <100*109 platelets per liter (/L) in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP is defined as: >=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Timepoint [11] 0 0
From the first assessment at which the criteria for <= 1% BCR-ABL1IS are met until the earliest date at which loss of <= 1% BCR-ABL1IS occurs, or the criteria for progression are met (up to 6.3 years)
Secondary outcome [12] 0 0
DOR for MMR - Duration of MMR is defined as the interval between the first assessment at which the criteria for MMR are met until the earliest date at which loss of MMR occurs, or the criteria for progression (progression to AP or BP of CML) are met. Participants remaining in MMR will be censored at the last date at which the criteria for MMR are met. Loss of MMR is an increase to >1% of BCR-ABL1IS. Progression to AP is defined as: >= 15% and <30% blasts in peripheral blood or bone marrow or >=20% basophils in peripheral blood or bone marrow or >=30% blasts + promyelocytes in peripheral blood or bone marrow (but <30% blasts) or <100*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP is defined as: >=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Timepoint [12] 0 0
From the first assessment at which the criteria for MMR are met until the earliest date at which loss of MMR occurs, or the criteria for progression are met (up to 6.3 years)
Secondary outcome [13] 0 0
DOR in Responders - Responders are defined as those participants who meet all of the following: are randomized and treated, respond at 12 months after the initiation of study treatment, and undergo baseline polymerase chain reaction (PCR) assessment.
Timepoint [13] 0 0
Baseline up to 6.3 years
Secondary outcome [14] 0 0
Time to Response
Timepoint [14] 0 0
Baseline up to 6.3 years
Secondary outcome [15] 0 0
Percentage of Participants With Progression to AP or BP CML - Progression to AP is defined as: >=15% and <30% blasts in peripheral blood or bone marrow or >=20% basophils in peripheral blood or bone marrow or >=30% blasts + promyelocytes in peripheral blood or bone marrow (but <30% blasts) or <100*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP is defined as: >=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Timepoint [15] 0 0
From first dose date of study treatment until death due to any cause, censored at the last response assessment (up to 6.3 years)
Secondary outcome [16] 0 0
Progression-free Survival (PFS) - PFS is defined as the interval between the first dose date of study treatment and the first date at which the criteria for progression are met (progression to the AP or BP of CML), or death due to any cause, censored at the last response assessment. Progression to AP is defined as: >=15% and <30% blasts in peripheral blood or bone marrow or >=20% basophils in peripheral blood or bone marrow or >=30% blasts + promyelocytes in peripheral blood or bone marrow (but <30% blasts) or <100*109 platelets/L in peripheral blood unrelated to therapy or cytogenetic, genetic evidence of clonal evolution, and no extramedullary disease. Progression to BP is defined as: >=30% blasts in peripheral blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Timepoint [16] 0 0
From first dose date of study treatment until first date at which criteria for progression are met, or death due to any cause, censored at the last response assessment (up to 6.3 years)
Secondary outcome [17] 0 0
Overall Survival (OS) - OS is defined as the interval between the first does of study treatment and death due to any cause, censored at the last contact date when the participant was alive.
Timepoint [17] 0 0
From first dose date of study treatment until death due to any cause, censored at the last contact date when the participant was alive (up to 6.3 years)

Eligibility
Key inclusion criteria
1. Have CP-CML and have received at least two prior TKI therapies and have demonstrated
resistance to treatment OR have documented history of presence of T315I mutation after
receiving any number of prior TKI.

o The diagnosis of chronic myeloid leukemia (CML) will be made using standard
hematopathologic and cytogenetic criteria; CP-CML will be defined by all of the
following: i <15% blasts in bone marrow ii <30% blasts plus promyelocytes in bone
marrow iii <20% basophils in peripheral blood. iv >= 100*10^9/liter (L) platelets
(>=100,000/mm^3). v No evidence of extramedullary disease except hepatosplenomegaly vi
No prior diagnosis of AP-CML, and BP-CML

o Cytogenetic assessment at screening must demonstrate the BCR-ABL1 fusion by presence
of the t(9;22) Philadelphia chromosome.

i Variant translocations are only allowed provided they meet inclusion criterion 1d.

o Resistance to prior TKI therapy is defined as follows (participants must meet at
least 1 criterion): i Three months after the initiation of prior TKI therapy: No
cytogenetic response (>95% Ph+) or failure to achieve CHR or new mutation ii Six
months after the initiation of prior TKI therapy: BCR-ABL1IS >10% and/or Ph+ >65% or
new mutation iii Twelve months after the initiation of prior TKI therapy: BCR ABL1IS
>10% and/or Ph+ >35% or new mutation iv At any time after the initiation of prior TKI
therapy, the development of a new BCR-ABL1 kinase domain mutation(s) v At any time
after the initiation of prior TKI therapy, the development of new clonal evolution vi
At any time after the initiation of prior TKI therapy, the loss of CHR, or CCyR, or
the confirmed loss of MMR in 2 consecutive tests, one of which has a BCR-ABL1IS
transcript level of >=1% or new mutation

o >1% of BCR-ABL1IS as shown by real-time polymerase chain reaction

2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

3. Have adequate renal function as defined by the following criterion:

- Serum creatinine <=1.5*ULN for institution

- Estimated creatinine clearance >=30 milliliter per minute (mL/min)
(Cockcroft-Gault formula)

4. Have adequate hepatic function as defined by the following criteria:

- Total serum bilirubin <=1.5*ULN, unless due to Gilbert's syndrome

- Alanine transaminase (ALT) <=2.5*ULN, or <=5*ULN if leukemic infiltration of the
liver is present

- Aspartate transaminase (AST) <=2.5*ULN, or <=5*ULN if leukemic infiltration of
the liver is present

5. Have normal pancreatic status as defined by the following criterion:

o Serum lipase and amylase <=1.5*ULN

6. Have normal QT interval corrected (Frederica) (QTcF) interval on screening
electrocardiogram (ECG) evaluation, defined as QTcF of <=450 milliseconds (ms) in
males or <=470 ms in females.

7. Have a negative pregnancy test documented prior to enrollment (for females of
childbearing potential).

8. Agree to use a highly effective form of contraception with sexual partners from
randomization through at least 4 months after the end of treatment (for female and
male participants who are fertile).

9. Provide written informed consent.

10. Be willing and able to comply with scheduled visits and study procedures.

11. Have recovered from toxicities related to prior anticancer therapy to National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 grade
<=1.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have used any approved TKIs or investigational agents within 2 weeks or 6 half-lives
of the agent, whichever is longer, prior to receiving study drug.

2. Received interferon, cytarabine, or immunotherapy within 14 days, or any other
cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior
to receiving the first dose of ponatinib, or have not recovered (>grade 1 by NCI
CTCAE, version 4.0) from AEs (except alopecia), due to agents previously administered.

3. Have undergone autologous or allogeneic stem cell transplant <60 days prior to
receiving the first dose of ponatinib; have any evidence of ongoing graft-versus-host
disease (GVHD) or GVHD requiring immunosuppressive therapy.

4. Are being considered for hematopoietic stem cell transplant (HSCT) within 6-12 months
of enrollment (note: ponatinib is not to be used as a bridge to HSCT in this trial).

5. Are taking medications with a known risk of Torsades de Pointes.

6. Have previously been treated with ponatinib.

7. Have active CNS disease as evidenced by cytology or pathology; in the absence of
clinical CNS disease, lumbar puncture is not required. History itself of CNS
involvement is not exclusionary if CNS has been cleared with a documented negative
lumbar puncture.

8. Have clinically significant, uncontrolled, or active cardiovascular disease,
specifically including, but not restricted to:

- Any history of myocardial infarction (MI), unstable angina, cerebrovascular
accident, or Transient Ischemic Attack (TIA)

- Any history of peripheral vascular infarction, including visceral infarction

- Any revascularization procedure, including the placement of a stent

- Congestive heart failure (CHF) (New York Heart Association [NYHA] class III or
IV) within 6 months prior to enrollment, or left ventricular ejection fraction
(LVEF) less than lower limit of normal, per local institutional standards, within
6 months prior to enrollment

- History of clinically significant (as determined by the treating physician)
atrial arrhythmia or any history of ventricular arrhythmia

- Venous thromboembolism, including deep venous thrombosis or pulmonary embolism,
within 6 months prior to enrollment

9. Have uncontrolled hypertension (that is, >150 and >90 for systolic blood pressure
(SBP) and diastolic blood pressure (DBP) respectively). Participants with hypertension
should be under treatment at study entry to ensure blood pressure control. Those
requiring 3 or more antihypertensive medications should be discussed with the medical
monitor.

10. Have poorly controlled diabetes defined as HbA1c values of >7.5%. Participants with
preexisting, well-controlled diabetes are not excluded.

11. Have a significant bleeding disorder unrelated to CML.

12. Have a history of alcohol abuse.

13. Have a history of either acute pancreatitis within 1 year of study enrollment or of
chronic pancreatitis.

14. Have malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drug.

15. Have a history of another malignancy, other than cervical cancer in situ or basal cell
or squamous cell carcinoma of the skin; the exception is if participants have been
disease-free for at least 5 years, and are deemed by the investigator to be at low
risk for recurrence of that malignancy.

16. Are pregnant or lactating.

17. Have undergone major surgery (with the exception of minor surgical procedures, such as
catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib.

18. Have an active infection which requires intravenous antibiotics.

19. Have a known history of human immunodeficiency virus infection; testing is not
required in the absence of prior documentation or known history.

20. Have any condition or illness that, in the opinion of the investigator, would
compromise participant safety or interfere with the evaluation of the drug.

21. Have hypersensitivity to the ponatinib active substance or to any of its inactive
ingredients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
Saskatchewan
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Chile
State/province [20] 0 0
Valparaiso
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha
Country [22] 0 0
Czechia
State/province [22] 0 0
Olomouc
Country [23] 0 0
Denmark
State/province [23] 0 0
\Aarhus
Country [24] 0 0
France
State/province [24] 0 0
Aquitaine
Country [25] 0 0
France
State/province [25] 0 0
Lorraine
Country [26] 0 0
France
State/province [26] 0 0
Midi-pyrenees
Country [27] 0 0
France
State/province [27] 0 0
NORD Pas-de-calais
Country [28] 0 0
France
State/province [28] 0 0
PAYS DE LA Loire
Country [29] 0 0
France
State/province [29] 0 0
Poitou-charentes
Country [30] 0 0
France
State/province [30] 0 0
Provence Alpes COTE D'azur
Country [31] 0 0
Germany
State/province [31] 0 0
Baden-wuerttemberg
Country [32] 0 0
Germany
State/province [32] 0 0
Mecklenburg-vorpommern
Country [33] 0 0
Germany
State/province [33] 0 0
Nordrhein-westfalen
Country [34] 0 0
Germany
State/province [34] 0 0
Thuringen
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Hong Kong
State/province [37] 0 0
Hong Kong
Country [38] 0 0
Italy
State/province [38] 0 0
Monza E Brianza
Country [39] 0 0
Italy
State/province [39] 0 0
Pesaro E Urbino
Country [40] 0 0
Italy
State/province [40] 0 0
Catania
Country [41] 0 0
Italy
State/province [41] 0 0
Genova
Country [42] 0 0
Italy
State/province [42] 0 0
Pescara
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Italy
State/province [44] 0 0
Verona
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Poland
State/province [46] 0 0
Dolnoslaskie
Country [47] 0 0
Poland
State/province [47] 0 0
Lodzkie
Country [48] 0 0
Poland
State/province [48] 0 0
Malopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Mazowieckie
Country [50] 0 0
Poland
State/province [50] 0 0
Pomorskie
Country [51] 0 0
Portugal
State/province [51] 0 0
Lisboa
Country [52] 0 0
Portugal
State/province [52] 0 0
Porto
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Rostov
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Chelyabinsk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Kemerovo
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Moscow
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Saint Petersburg
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Samara
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Saratov
Country [60] 0 0
Singapore
State/province [60] 0 0
Singapore
Country [61] 0 0
Spain
State/province [61] 0 0
Andalucia
Country [62] 0 0
Spain
State/province [62] 0 0
LAS Palmas
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Valencia
Country [66] 0 0
Sweden
State/province [66] 0 0
Uppsala
Country [67] 0 0
Switzerland
State/province [67] 0 0
Zurich
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taipei
Country [69] 0 0
United Kingdom
State/province [69] 0 0
England
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ariad Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the efficacy of ponatinib administered in 3
starting doses (45 milligram [mg], 30 mg, and 15 mg daily) in participants with CP-CML who
are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as
measured by less than or equal to (<=) 1 percent (%) Breakpoint Cluster Region-Abelson
Transcript Level using International Scale (BCR-ABL1IS) at 12 months.
Trial website
https://clinicaltrials.gov/show/NCT02467270
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications