Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01964430




Registration number
NCT01964430
Ethics application status
Date submitted
14/10/2013
Date registered
17/10/2013
Date last updated
28/06/2023

Titles & IDs
Public title
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Scientific title
A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
Secondary ID [1] 0 0
2013-003398-91
Secondary ID [2] 0 0
ABI-007-PANC-003
Universal Trial Number (UTN)
Trial acronym
apact
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Neoplasms 0 0
Digestive System Neoplasms 0 0
Neoplasms by Site 0 0
Neoplasms 0 0
Endocrine Gland Neoplasms 0 0
Pancreatic Diseases 0 0
Digestive System Diseases 0 0
Endocrine System Diseases 0 0
Gemcitabine 0 0
Antimetabolites, Antineoplastic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Any cancer
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine

Experimental: nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2 - Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.

Active comparator: Gemcitabine 1000 mg/m^2 - Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.


Treatment: Drugs: nab-Paclitaxel
nab-Paclitaxel 125 mg/m\^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.

Treatment: Drugs: Gemcitabine
Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
Timepoint [1] 0 0
Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone
Secondary outcome [1] 0 0
Kaplan Meier Estimate of Overall Survival (OS)
Timepoint [1] 0 0
From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alone
Secondary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
Timepoint [2] 0 0
From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).
Secondary outcome [3] 0 0
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
Timepoint [3] 0 0
From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).

Eligibility
Key inclusion criteria
1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
3. Subject should be able to start treatment no later than 12 weeks postsurgery.
4. =18 years of age at the time of signing the informed consent form (ICF).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Acceptable hematology parameters:

* Absolute neutrophil count (ANC) =1500 cell/mm^3
* Platelet count =100,000/mm^3
* Hemoglobin (Hgb) =9 g/dL
7. Acceptable blood chemistry levels:

* Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) =2.5 × upper limit of normal range (ULN)
* Total bilirubin = upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
* Alkaline phosphatase = 2.5 x ULN
* Serum creatinine within upper limits of normal or calculated clearance =50 mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead
8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:

1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
2. Presence of or history of metastatic pancreatic adenocarcinoma
3. Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
5. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
7. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:

1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
2. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
866
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Local Institution - 505 - Garran
Recruitment hospital [3] 0 0
Local Institution - 501 - Darlinghurst
Recruitment hospital [4] 0 0
Local Institution - 507 - St Leonards
Recruitment hospital [5] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [6] 0 0
Local Institution - 504 - Herston
Recruitment hospital [7] 0 0
ICON Cancer Center - Milton
Recruitment hospital [8] 0 0
Local Institution - 502 - Milton
Recruitment hospital [9] 0 0
Local Institution - 506 - Bentleigh East
Recruitment hospital [10] 0 0
Local Institution - 508 - Subiaco
Recruitment hospital [11] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [12] 0 0
Monash Medical Centre Moorabbin Campus - Bentleigh East
Recruitment hospital [13] 0 0
Saint Vincent's Hospital - Darlinghurst
Recruitment hospital [14] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [15] 0 0
Local Institution - 509 - Heidelberg
Recruitment hospital [16] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [17] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [18] 0 0
Local Institution - 503 - Malvern
Recruitment hospital [19] 0 0
Local Institution - 500 - Randwick
Recruitment hospital [20] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [21] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
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New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [18] 0 0
United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Wels
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Austria
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Wiener Neustadt
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Edegem
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Gent
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Leuven
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Ontario
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Hradec Kralove
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Zlin
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Aalborg
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Herlev
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Odense C
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Oulun Lääni
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Finland
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Helsinki
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Tampere
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Turku
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Angers cedex 09
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Creteil
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Lille
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Lyon Cedex 3
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Lyon
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France
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Paris
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France
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Poitiers Cedex
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France
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Toulose
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Germany
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Bayern
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Frechen
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Germany
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Friedrichshafen
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Germany
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Greifswald
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Germany
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Hamburg
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Germany
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Köln
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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München
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Germany
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Tübingen
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Germany
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Würzburg
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Hong Kong
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Hong Kong
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Hong Kong
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Sha Tin
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Szeged
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Szolnok
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Ireland
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Cork
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Ireland
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Dublin 4
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Italy
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Umbria
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Italy
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Ancona
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Italy
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Bologna
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Italy
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Firenze
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Italy
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Meldola
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Italy
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Milano
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Rozzano (MI)
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Italy
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San Giovanni Rotondo
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Italy
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Terni
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Italy
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Verona
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Eindhoven
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Netherlands
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Zwolle
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Portugal
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Lisboa
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Portugal
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Porto
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Singapore
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Singapore
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Cantabria
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Spain
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Barcelona
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Madrid
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Spain
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Malaga
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Spain
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Pamplona/ Navarra
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Spain
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Santander
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Spain
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Santiago De Compostela
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Spain
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Sevilla
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Taiwan
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Taichung
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Taiwan
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Tainan, Taiana
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Taiwan
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Tapei
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Sheffield South Yorkshire
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United Kingdom
State/province [118] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01964430