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AzTrials

MyelofibrosisPhase 3JUMPNCT01493414

INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

A Phase 3 study testing INC424 in people with Myelofibrosis, run by Novartis Pharmaceuticals at 273 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis
What is being tested?
INC424
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,233 participants
Where
273 sitesin 25 countries
Study dates
16 Aug 2011to 26 Jan 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Patients must not be eligible for another ongoing INC424 clinical trial.
  2. Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised International Standard Criteria, irrespective of JAK2 mutation status..
  3. Patients with PMF requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen (assessment to occur at the Screening Visit). The prognostic factors, defined by the International Working Group are:
  • Age > 65 years;
  • Presence of constitutional symptoms (weight loss, fever, night sweats);
  • Marked anemia (Hgb < 10g/dL)*;
  • Leukocytosis (history of white blood cell (WBC) > 25 x109/L);
  • Circulating blasts > 1%. * A hemoglobin value < 10 g/dL must be demonstrated during the Screening Visit for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk factors.
  1. Patients with Intermediate-1 disease and splenomegaly must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion.
  2. Patients must have a peripheral blood blast count of < 10%.
  3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  4. Fedratinib pretreated patients with documented complete physical examination including full neurologic examination and cardiology assessment, thiamine level testing, and MRI of the brain if indicated based on signs or symptoms. Patients pretreated with fedratinib should have completed or be receiving thiamine supplementation according to the investigator's instructions.

Main Exclusion Criteria:

  1. Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
  2. Patients with history of malignancy in past 3 years except for treated, early-stage squamous or basal cell carcinoma in situ.
  3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral INC424 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
  4. Patients with cardiac disease which in the Investigator's opinion may jeopardize the safety of the patient or the compliance with the protocol.
  5. Patients with currently uncontrolled or unstable angina, rapid or paroxysmal atrial fibrillation or recent (approximately 6 months) myocardial infarction or acute coronary syndrome.
  6. Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
  7. Patients with known active hepatitis A, B, C or who are HIV-positive.
  8. Patients with inadequate bone marrow reserve at the Baseline visit as demonstrated by:
  • Absolute neutrophil count (ANC) ≤ 1000/µL.
  • Platelet count < 50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
  1. Patients with any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason.
  2. In the case of ruxolitinib pretreated patients, ruxolitinib primary resistant patients defined as:
  • No spleen reduction within the first 12 weeks after front line therapy with ruxolitinib. AND
  • No reduction in symptoms within the first 12 weeks after first-line treatment with ruxolitinib.
  1. In the case of ruxolitinib pretreated patients, patients discontinuing ruxolitinib due to a Grade 4 Adverse event (AE) related or suspected to be related to ruxolitinib.

Trial locations and contacts

273 sites in 25 countries.

273 sites in 25 countries

Italy58 sites

  • Novartis Investigative Site

    Alessandria, AL, 15100

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Bergamo, BG, 24128

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Cagliari, CA, 09100

  • Novartis Investigative Site

    Cagliari, CA, 09126

  • Novartis Investigative Site

    Catania, CT, 95100

  • Novartis Investigative Site

    Catania, CT, 95124

  • Novartis Investigative Site

    Catanzaro, CZ, 88100

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Naples, 80132

  • Novartis Investigative Site

    Naples, 80136

  • Novartis Investigative Site

    Novara, 28100

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Pagani, SA, 84016

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pavia, 27100

  • Novartis Investigative Site

    Perugia, 06129

  • Novartis Investigative Site

    Pesaro, PU, 61100

  • Novartis Investigative Site

    Pescara, PE, 65124

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Ravenna, RA, 48100

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Rionero in Vulture, PZ, 85028

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00144

  • Novartis Investigative Site

    Roma, RM, 00152

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Roma, RM, 00185

  • Novartis Investigative Site

    Ronciglione, VT, 01100

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Taranto, TA, 74100

  • Novartis Investigative Site

    Terni, TR, 05100

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Treviso, TV, 31100

  • Novartis Investigative Site

    Udine, UD, 33100

  • Novartis Investigative Site

    Varese, VA, 21100

  • Novartis Investigative Site

    Venezia, VE, 30174

  • Novartis Investigative Site

    Verona, VR, 37126

  • Novartis Investigative Site

    Vicenza, VI, 36100

Other trials in Italy

Germany55 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 14195

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bonn, 53113

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Bottrop, 46236

  • Novartis Investigative Site

    Bremen, 28177

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Cologne, 50671

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Darmstadt, 64283

  • Novartis Investigative Site

    Dortmund, 44263

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Duisburg, 47166

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Frankfurt (Oder), 15236

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Friedrichshafen, 88045

  • Novartis Investigative Site

    Goslar, 38642

  • Novartis Investigative Site

    Göttingen, D-37075

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Halle, 06110

  • Novartis Investigative Site

    Hamburg, 20099

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamm, 59063

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Hildesheim, 31135

  • Novartis Investigative Site

    Ingolstadt, 85049

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Kiel, D-24116

  • Novartis Investigative Site

    Leer, 26789

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    Moers, 47441

  • Novartis Investigative Site

    München, 80331

  • Novartis Investigative Site

    München, 81241

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Nuremberg, 90403

  • Novartis Investigative Site

    Oldenburg, 26133

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Stuttgart, 70376

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

Spain47 sites

  • Novartis Investigative Site

    Alcalá de Henares, Madrid, 28805

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Burgos, Castille and León, 09005

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Ferrol, A Coruna, 15405

  • Novartis Investigative Site

    Girona, Catalonia, 17007

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Jaén, Andalusia, 23007

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, Las Palmas de G.C, 35010

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35016

  • Novartis Investigative Site

    Logroño, La Rioja, 26006

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    San Sebastián de los Reyes, Madrid, 28702

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Tarragona, Catalonia, 43005

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46026

  • Novartis Investigative Site

    Valladolid, Castille and León, 47012

  • Novartis Investigative Site

    Zaragoza, 50009

  • Novartis Investigative Site

    Zaragoza, 50015

Other trials in Spain

Belgium15 sites

  • Novartis Investigative Site

    Antwerp, 2060

  • Novartis Investigative Site

    Arlon, Luxembourg, 1210

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Wilrijk, 2610

  • Novartis Investigative Site

    Yvoir, 5530

Other trials in Belgium

Canada12 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 1V7

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    Moncton, New Brunswick, E1C 6Z8

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1S6

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7N 4H4

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, British Columbia, V6Z1Y6

  • Novartis Investigative Site

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Brazil10 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970

  • Novartis Investigative Site

    Curitiba, Paraná, 80060-900

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-050

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20.211-030

  • Novartis Investigative Site

    São Paulo, São Paulo, 01224-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05651-901

  • Novartis Investigative Site

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

Austria7 sites

  • Novartis Investigative Site

    Graz, A-8036

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Linz, A-4010

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, 1140

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Russia7 sites

  • Novartis Investigative Site

    Irkutsk, 664079

  • Novartis Investigative Site

    Moscow, 125167

  • Novartis Investigative Site

    Nizhny Novgorod, 603126

  • Novartis Investigative Site

    Novosibirsk, 630051

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Saint Petersburg, 191024

  • Novartis Investigative Site

    Saint Petersburg, 197341

Other trials in Russia

Argentina6 sites

  • Novartis Investigative Site

    Buenos Aires, C1114AAN

  • Novartis Investigative Site

    CABA, Buenos Aires, 1209

  • Novartis Investigative Site

    CABA, Buenos Aires, C1221ADC

  • Novartis Investigative Site

    Córdoba, X5016KEH

  • Novartis Investigative Site

    Corrientes, W3410AVV

  • Novartis Investigative Site

    Paraná, Entre Ríos Province, E3100BBJ

Other trials in Argentina

Israel6 sites

  • Novartis Investigative Site

    Afula, 1834111

  • Novartis Investigative Site

    Haifa, 3339419

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5266202

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Poland6 sites

  • Novartis Investigative Site

    Gdansk, 80-958

  • Novartis Investigative Site

    Katowice, 40-027

  • Novartis Investigative Site

    Krakow, 31-503

  • Novartis Investigative Site

    Opole, 45-372

  • Novartis Investigative Site

    Torun, 87-100

  • Novartis Investigative Site

    Warsaw, 02-776

Other trials in Poland

Hungary5 sites

  • Novartis Investigative Site

    Budapest, H-1097

  • Novartis Investigative Site

    Debrecen, H-4032

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Szeged, H-6720

  • Novartis Investigative Site

    Szombathely, 9700

Other trials in Hungary

Mexico5 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44280

  • Novartis Investigative Site

    Hermosillo, Sonora, 83000

  • Novartis Investigative Site

    Mexico City, Mexico City, 06726

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64020

  • Novartis Investigative Site

    Puebla City, 72000

Other trials in Mexico

Portugal5 sites

  • Novartis Investigative Site

    Coimbra, 3000-075

  • Novartis Investigative Site

    Faro, 8000-386

  • Novartis Investigative Site

    Lisbon, 1749-035

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Vila Real, 5000 - 508

Other trials in Portugal

South Africa5 sites

  • Novartis Investigative Site

    Cape Town, Western Province, 7801

  • Novartis Investigative Site

    Johannesburg, 2196

  • Novartis Investigative Site

    Pretoria, 0001

  • Novartis Investigative Site

    Pretoria, 0027

  • Novartis Investigative Site

    Soweto, Gauteng, 2013

Other trials in South Africa

Czechia4 sites

  • Novartis Investigative Site

    Brno, Czech Republic, 639 00

  • Novartis Investigative Site

    Hradec Králové, Czech Republic, 500 05

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Prague, Czech Republic, 128 20

Other trials in Czechia

Greece4 sites

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, GR, GR-106 76

  • Novartis Investigative Site

    Athens, GR 11527

  • Novartis Investigative Site

    Pátrai, 265 00

Other trials in Greece

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

Other trials in Thailand

Tunisia4 sites

  • Novartis Investigative Site

    Sfax, Tunisie, 3029

  • Novartis Investigative Site

    Sousse, 4000

  • Novartis Investigative Site

    Tunis, 1008

  • Novartis Investigative Site

    Tunis

Other trials in Tunisia

Colombia2 sites

  • Novartis Investigative Site

    Bogota, Cundinamarca, 111411

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

Saudi Arabia2 sites

  • Novartis Investigative Site

    Jeddah, 21423

  • Novartis Investigative Site

    Riyadh, 11426

Other trials in Saudi Arabia

Algeria1 site

  • Novartis Investigative Site

    Algiers

Other trials in Algeria

Ireland1 site

  • Novartis Investigative Site

    Cork, Cork

Other trials in Ireland

Morocco1 site

  • Novartis Investigative Site

    Marrakesh

Other trials in Morocco

Slovakia1 site

  • Novartis Investigative Site

    Bratislava, 85107

Other trials in Slovakia

About this study

Official title: An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-essential Thrombocythemia Myelofibrosis (PET-MF).

The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment.

Conditions
Myelofibrosis
Being tested
INC424
Keywords
Myelofibrosis, Primary myelofibrosis, PMF, Post polycythemia myelofibrosis, PPV MF, Post-essential thrombocythemia myelofibrosis, PET-MF, INC424, Ruxolitinib
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INC424Drug

    Also called Ruxolitinib

    All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally.

Study groups in NCT01493414
Study groupRoleWhat they receive
INC424Experimental5 - 25 mg twice a day (BID)
Receives: Drug: INC424

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years

    An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above.

    Measured: Baseline up to approximately 5 years

Secondary outcomes (6)

  1. Percentage of Participants With at Least 50% Reduction in Spleen Length

    Spleen length was assessed by manual palpation. Assessment of spleen response was repeated until early discontinuation of the study drug and also at study completion (28 days post end of treatment visit).

    Measured: Baseline up to approximately 5 years

  2. Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length

    Overall response is analyzed using the spleen response, as assessed by the investigator and also by deriving the response using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.

    Participants with spleen length at baseline between 5 and 10 cm were reported as Responders if reporting non palpable spleen; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 100% from baseline in spleen length.

    Participants with spleen length at baseline more than 10 cm were reported as Responders with spleen reduction of 50% from baseline; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 50% from baseline in spleen length.

    Measured: Baseline up to approximately 5 years

  3. Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years

    ECOG Performance Score has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. 5 = Death.

    Measured: Baseline up to approximately 5 years

  4. Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48

    The FACT-Lym questionnaire consists of a total of 42 questions divided between five subscales (i.e., physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma subscale). Each subscale questionnaire rates each question on a 5-point scale from 0 = Not at all to 4 = Very much. These scores were summed to three total sum scores, namely FACT-Lym score, FACT-Lym Trial Outcome Index (TOI), FACT-General (FACT-G) and FACT-Lym total score. Total scores: FACT-Lym=0-60, FACT-TOI=0-116, FACT-G total=0-108, FACT-Lym Total= 0-168. Higher scores are reflective of better HRQoL.

    Measured: Baseline and Week 48

  5. Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status

    Improvement was defined by the upper limit of the minimally important difference (MID). Patients with the best possible score at Baseline were excluded from this analysis because their HRQoL cannot be further improved. Responders and non-responders for each endpoint were defined based on change from baseline scores using pre specified cut-off points. Patients with an improved score compared to Baseline, for which the magnitude of the change was at least the cutoff value, were classified as responders; otherwise, as non-responders. The responder cutoff: ECOG cutoff=1, range=0 to 5, FACT-Lym cutoff=5.4, range 0-60, FACIT-Fatigue =5 and range=0-52.The median time to first improvement was estimated using the Kaplan Meier method and time to improvement event was determined based on upper bound of the MID. The time to improvement was calculated from the date of first study drug administration.

    Measured: Baseline up to approximately 5 years

  6. Medical Resource Utilization up to 5 Years

    Percentage of patients requiring medical resources (blood transfusions, hospitalization, emergency room visits, general practitioners or specialists consultations, urgent care or splenic irradiation) up to 5 years.

    Measured: Baseline up to approximately 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study start16 Aug 2011
  3. Primary completion26 Jan 2017
  4. Study completion26 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493414
Sponsor's protocol ID
CINC424A2401
Other IDs
2010-024473-39
Acronym
JUMP
Status last verified
Oct 2018
First submitted
13 Dec 2011
Last updated
26 Apr 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gupta V, Griesshammer M, Martino B, Foltz L, Tavares R, Al-Ali HK, Giraldo P, Guglielmelli P, Lomaia E, Bouard C, Paley C, Tiwari R, Zor E, Raanani P. Analysis of predictors of response to ruxolitinib in patients with myelofibrosis in the phase 3b expanded-access JUMP study. Leuk Lymphoma. 2021 Apr;62(4):918-926. doi: 10.1080/10428194.2020.1845334. Epub 2020 Nov 19.

    PubMed 33210570

  • Al-Ali HK, Griesshammer M, Foltz L, Palumbo GA, Martino B, Palandri F, Liberati AM, le Coutre P, Garcia-Hernandez C, Zaritskey A, Tavares R, Gupta V, Raanani P, Giraldo P, Hanel M, Damiani D, Sacha T, Bouard C, Paley C, Tiwari R, Mannelli F, Vannucchi AM. Primary analysis of JUMP, a phase 3b, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts. Br J Haematol. 2020 Jun;189(5):888-903. doi: 10.1111/bjh.16462. Epub 2020 Feb 4.

    PubMed 32017044

  • Tavares R, Souza CA, Paley C, Bouard C, Tiwari R, Pasquini R. A subgroup analysis of JUMP, a phase IIIb, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis in a Brazilian cohort. Hematol Transfus Cell Ther. 2020 Jan-Mar;42(1):46-53. doi: 10.1016/j.htct.2019.01.009. Epub 2019 Apr 25.

    PubMed 31235325

  • Al-Ali HK, Griesshammer M, le Coutre P, Waller CF, Liberati AM, Schafhausen P, Tavares R, Giraldo P, Foltz L, Raanani P, Gupta V, Tannir B, Ronco JP, Ghosh J, Martino B, Vannucchi AM. Safety and efficacy of ruxolitinib in an open-label, multicenter, single-arm phase 3b expanded-access study in patients with myelofibrosis: a snapshot of 1144 patients in the JUMP trial. Haematologica. 2016 Sep;101(9):1065-73. doi: 10.3324/haematol.2016.143677. Epub 2016 May 31.

    PubMed 27247324

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INC424 in people with Myelofibrosis, run by Novartis Pharmaceuticals at 273 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in Italy, Germany, Spain, Belgium, Canada and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years (time frame: Baseline up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493414, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.

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