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JOURNAL ONKOLOGIE – STUDIE
FREEDOM2

An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Rekrutierend

NCT-Nummer:
NCT03952039

Studienbeginn:
September 2019

Letztes Update:
08.04.2021

Wirkstoff:
Fedratinib, Best Available Therapy (BAT)

Indikation (Clinical Trials):
Polycythemia Vera, Primary Myelofibrosis, Polycythemia, Thrombocytosis, Thrombocythemia, Essential

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Celgene

Collaborator:
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

Studienleiter

Vishwanath Gharpure, MD
Study Director
Celgene Corporation

Kontakt

Associate Director Clinical Trial Disclosure
Kontakt:
Phone: 1-888-260-1599
E-Mail: clinicaltrialdisclosure@celgene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 112)

Klinikum der Johann Wolfgang Goethe Universitat
60590 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Halle Saale
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Jena
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Magdeburg A oeR
39120 Magdeburg
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
University of Heidelberg - Universitatsklinikum Mannheim
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Johannes Wiesling Klinikum Minden
32429 Minden
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
TU München - Klinikum rechts der Isar
81675 München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Saint Vincent's Hospital
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
Peninsula Private Hospital
3199 Frankston
AustraliaRekrutierend» Google-Maps
Eastern Health Clinical School
3128 Box Hill
AustraliaRekrutierend» Google-Maps
Medical University Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Salzburger Landkliniken St. Johanns-Spital
5020 Salzburg
AustriaRekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
Centre Hospitalier de Jolimont-Lobbes
7100 La Louvière-(Haine St-Paul)
BelgiumRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Liege - Sart Tilman
4000 Liege
BelgiumRekrutierend» Google-Maps
Cliniques Universitaires UCL de Mont-Godine
5530 Yvoir
BelgiumRekrutierend» Google-Maps
Peking University People's Hospital
100044 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Peking Union Medical College Hospital
100730 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Medical University Union Hospital
350001 Fuzhou
ChinaNoch nicht rekrutierend» Google-Maps
Guangdong General Hospital
510080 Guangzhou, Guangdong
ChinaRekrutierend» Google-Maps
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
210029 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Chinese Academy of Medical Sciences & Peking Union Medical College
300041 Tianjin
ChinaRekrutierend» Google-Maps
Fakultni Nemocnice Brno
625 00 Brno
CzechiaNoch nicht rekrutierend» Google-Maps
Fakultni Nemocnice Ostrava
708 52 Ostrava-Poruba
CzechiaRekrutierend» Google-Maps
Vseobecna Fakultni Nemocnice v Praze
128 08 Prague 2
CzechiaRekrutierend» Google-Maps
Centre Hospitalier de Lens
62307 Lens Cedex
FranceRekrutierend» Google-Maps
CHU Nice Hopital de L'Archet 2
06200 Nice Cedex 3
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau
30029 Nimes Cedex 9
FranceRekrutierend» Google-Maps
CHRU - Hopital du Haut Leveque
33604 Pessac
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon Sud - Hospices Civils de Lyon Groupement Hospitalier Sud
69495 Pierre-Benite
FranceRekrutierend» Google-Maps
CHU Strasbourg - Hopital Civil
67091 Strasbourg
FranceRekrutierend» Google-Maps
Institut Universitaire du Cancer de Toulouse - Oncopole
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
Petz Aladar Megyei Oktato Korhaz
9023 Gyor
HungaryRekrutierend» Google-Maps
Somogy Megyei Kaposi Mor Oktato Korhaz
7400 Kaposvar
HungaryRekrutierend» Google-Maps
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
4400 Nyiregyhaza
HungaryRekrutierend» Google-Maps
Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont
6720 Szeged
HungaryRekrutierend» Google-Maps
Mater Misericordiae University Hospital
Dublin 7 Dublin
IrelandRekrutierend» Google-Maps
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
ASST Spedali Civili P.O. di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico
95123 Catania
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria Careggi
50134 Firenze
ItalyRekrutierend» Google-Maps
IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
20122 Milano
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Policlinico San Matteo
27100 Pavia
ItalyRekrutierend» Google-Maps
Policlinico Umberto I - Universita La Sapienza
00168 Roma
ItalyRekrutierend» Google-Maps
Universita Cattololica del Sacro Cuore
00168 Roma
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera S. Andrea - Università La Sapienza
00189 Roma
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
10126 Torino
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
33100 Udine
ItalyRekrutierend» Google-Maps
Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese
21100 Varese
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Integrata di Verona
37134 Verona
ItalyRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul St Marys Hospital College of Medicine The Catholic University of Korea
137-701 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Soon Chun Hyang University Hospital Seoul
140-887 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
3080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Radboud University Medical Center
6525 GA Nijmegen
NetherlandsRekrutierend» Google-Maps
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
60-569 Poznan
PolandNoch nicht rekrutierend» Google-Maps
Instytut Hematologii i Transfuzjologii w Warszawie
02-776 Warszawa
PolandNoch nicht rekrutierend» Google-Maps
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
50-556 Wroclaw
PolandRekrutierend» Google-Maps
FSBI Hematology Research Center Ministry of Healthcare of the Russian Federation
125167 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
125284 Moscow
Russian FederationRekrutierend» Google-Maps
City Clinical Hospital 40
129301 Moscow
Russian FederationRekrutierend» Google-Maps
Novosibirsk State Medical University (NSMU)
630066 Novosibirsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
191024 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Pavlov First Saint Petersburg State Medical University
197022 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
197341 St Petersburg
Russian FederationRekrutierend» Google-Maps
State Budgetary Healthcare Organization
362002 Vladikavkaz
Russian FederationNoch nicht rekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruna
15006 A Coruna
SpainNoch nicht rekrutierend» Google-Maps
Hospital General Universitario de Alicante
03010 Alicante
SpainRekrutierend» Google-Maps
Hospital Universitari Germans Trias i Pujol
8916 Badalona (Barcelona)
SpainRekrutierend» Google-Maps
Hospital Universitario Cruces
48903 Barakaldo
SpainRekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Instituto Catalan de Oncologia de Girona
17007 Gerona
SpainRekrutierend» Google-Maps
Hospital Universitario de Gran Canaria Dr. Negrin
35012 Las Palmas de Gran Canaria
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de la Victoria
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital General Universitario Morales Meseguer
30008 Murcia
SpainRekrutierend» Google-Maps
Universitario de Salamanca - Hospital Clinico
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario de Tenerife
38320 Santa Cruz de Tenerife
SpainNoch nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Santiago
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
B15 2TH Birmingham
United KingdomRekrutierend» Google-Maps
United Lincolnshire Hospitals NHS Trust
PE21 9QS Boston
United KingdomRekrutierend» Google-Maps
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
SE1 9RT London
United KingdomRekrutierend» Google-Maps
Imperial College Hammersmith Hospital
W12 0HS London
United KingdomRekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
Nottingham City Hospital
NG5 1PB Nottingham
United KingdomAbgeschlossen» Google-Maps
The Churchill Hospital
0X3 7LE Oxford
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This Phase 3, multicenter, randomized, two-arm, open-label study will include subjects with

intermediate or high-risk (as per the DIPSS score) primary myelofibrosis (PMF),

postpolycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia

myelofibrosis (post-ET MF). This study will be conducted in compliance with International

Council for Harmonisation (ICH) Good Clinical Practices (GCPs).

Study design includes:

- A 28-day Screening Period

- 2:1 Randomization to fedratinib or best available therapy (BAT)

- Stratification at Randomization according to:

- Spleen size by palpation: < 15 cm below left costal margin (LCM) versus ≥ 15 cm

below LCM

- Platelets ≥ 50 to < 100 x 109/L versus platelets ≥ 100 x 109/L

- Refractory or relapsed to ruxolitinib treatment versus intolerant to ruxolitinib

treatment

- Study Treatment Period (time on study drug plus 30 days after last dose)

- Subjects are allowed to crossover from BAT to the fedratinib arm after the Cycle 6

response assessment or before the Cycle 6 response assessment in the event of a

confirmed progression of splenomegaly by MRI/CT scan

- A Survival Follow-up Period for progression and survival

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Subject is at least 18 years of age at the time of signing the informed consent form

(ICF)

2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0,

1 or 2

3. Subject has diagnosis of primary myelofibrosis (PMF) according to the 2016 World

Health Organization (WHO) criteria, or diagnosis of post-ET or post-PV myelofibrosis

according to the IWG-MRT 2007 criteria, confirmed by the most recent local pathology

report

4. Subject has a DIPSS Risk score of Intermediate-2 or High

5. Subject has a measurable splenomegaly during the screening period as demonstrated by

spleen volume of ≥ 450 cm3 by MRI or CT-scan and by palpable spleen measuring ≥ 5 cm

below the left costal margin

6. Subject has a measurable total symptoms score (≥ 1) as measured by the Myelofibrosis

Symptom Assessment Form (MFSAF)

7. Subject has been previously exposed to ruxolitinib, and must meet at least one of the

following criteria (a and/or b)

1. Treatment with ruxolitinib for ≥ 3 months with inadequate efficacy response

(refractory) defined as < 10% spleen volume reduction by MRI or < 30% decrease

from baseline in spleen size by palpation or regrowth (relapsed) to these

parameters following an initial response

2. Treatment with ruxolitinib for ≥ 28 days complicated by any of the following

(intolerant):

- Development of a red blood cell transfusion requirement (at least 2

units/month for 2 months) or

- Grade ≥ 3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while

on treatment with ruxolitinib

8. Subject must have treatment-related toxicities from prior therapy resolved to Grade 1

or pretreatment baseline before start of last therapy prior to randomization

9. Subject must understand and voluntarily sign an ICF prior to any study-related

assessments/procedures being conducted

10. Subject is willing and able to adhere to the study visit schedule and other protocol

requirements

11. A female of childbearing potential (FCBP) must:

1. Have 2 negative pregnancy tests as verified by the Investigator during screening

prior to starting study treatment. She must agree to ongoing pregnancy testing

during the course of the study, and after end of study treatment. This applies

even if the subject practices true abstinence from heterosexual contact.

2. Either commit to true abstinence from heterosexual contact (which must be

reviewed on a monthly basis and source documented) or agree to use and be able to

comply with highly effective contraception without interruption, -14 days prior

to starting investigational product, during the study treatment (including dose

interruptions), and for 30 days after discontinuation of study treatment.

Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved

menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy,

or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does

not rule out childbearing potential) for at least 24 consecutive months (ie, has had

menses at any time in the preceding 24 consecutive months).

12. A male subject must:

Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a

condom during sexual contact with a pregnant female or a female of childbearing potential

while participating in the study, during dose interruptions and for at least 30 days

following investigational product discontinuation, or longer if required for each compound

and/or by local regulations, even if he has undergone a successful vasectomy

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

1. Platelets < 50 x 109/L

2. Absolute neutrophil count (ANC) < 1.0 x 109/L

3. White blood count (WBC) > 100 x 109/L

4. Myeloblasts ≥ 5 % in peripheral blood

5. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as per the Modification

of Diet in Renal Disease [MDRD] formula)

6. Serum amylase or lipase > 1.5 x upper limit of normal (ULN)

7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper

limit of normal (ULN)

8. Total bilirubin > 1.5 x ULN, subject's total bilirubin between 1.5 - 3.0 x ULN

are eligible if the direct bilirubin fraction is < 25% of the total bilirubin

2. Subject is pregnant or lactating female

3. Subject with previous splenectomy

4. Subject with previous or planned hematopoietic cell transplant

5. Subject with prior history of encephalopathy, including Wernicke's (WE)

6. Subject with signs or symptoms of encephalopathy, including WE (eg, severe ataxia,

ocular paralysis or cerebellar signs)

7. Subject with thiamine deficiency, defined as thiamine levels in whole blood below

normal range according to the central laboratory and not demonstrated to be corrected

prior to randomization

8. Subject with concomitant treatment with or use of pharmaceutical, herbal agents or

food known to be strong or moderate inducers of Cytochrome P450 3A4 (CYP3A4), or dual

CYP2C19 and CYP3A4 inhibitors

9. Subject on any chemotherapy, immunomodulatory drug therapy (eg, thalidomide,

interferon-alpha), anagrelide, immunosuppressive therapy, systemic corticosteroids >

10 mg/day prednisone or equivalent. Subjects who have had prior exposure to

hydroxyurea (eg, Hydrea) in the past may be enrolled into the study as long as it has

not been administered within 14 days prior to randomization

10. Subject has received ruxolitinib within 14 days prior to randomization

11. Subject with previous exposure to Janus kinase (JAK) inhibitor(s) other than

ruxolitinib treatment

12. Subject on treatment with aspirin with doses > 150 mg daily

13. Subject with major surgery within 28 days prior to randomization

14. Subject with diagnosis of chronic liver disease (eg, chronic alcoholic liver disease,

autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis,

hemochromatosis, non-alcoholic steatohepatitis)

15. Subject with prior malignancy other than the disease under study unless the subject

has not required treatment for the malignancy for at least 3 years prior to

randomization. However, subject with the following history/concurrent conditions

provided successfully treated may enroll: non-invasive skin cancer, in situ cervical

cancer, carcinoma in situ of the breast, incidental histologic finding of prostate

cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system),

or is free of disease and on hormonal treatment only

16. Subject with uncontrolled congestive heart failure (New York Heart Association

Classification 3 or 4)

17. Subject with known human immunodeficiency virus (HIV), known active infectious

Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC)

18. Subject with serious active infection

19. Subject with presence of any significant gastric or other disorder that would inhibit

absorption of oral medication

20. Subject is unable to swallow capsule

21. Subject with any significant medical condition, laboratory abnormality, or psychiatric

illness that would prevent the subject from participating in the study

22. Subject has any condition including the presence of laboratory abnormalities, which

places the subject at unacceptable risk if he/she were to participate in the study

23. Subject has any condition that confounds the ability to interpret data from the study

24. Subject with participation in any study of an investigational agent (drug, biologic,

device) within 30 days prior to randomization

25. Subject with a life expectancy of less than 6 months

Studien-Rationale

Primary outcome:

1. Proportion of subjects who have ≥ 35% SVR at end of cycle 6 (Time Frame - At the end of Cycle 1 (each cycle is 28 days)):
Spleen volume response rate (RR)



Secondary outcome:

1. Proportion of subjects with ≥ 50% reduction in total symptom scores measured by MFSAF at end of cycle 6 (Time Frame - Up to end of Cycle 6 (each cycle is 28 days)):
Symptom response rate (SRR)

2. Proportion of subjects who have ≥ 25% reduction in spleen volume at the end of cycle 6 (Time Frame - At the end of Cycle 1 (each cycle is 28 days)):
Spleen volume response rate (RR25)

3. Adverse Events (AEs) (Time Frame - Up to 30 days post last dose):
Number of participants with adverse event

4. Proportion of subjects who have ≥ 50% reduction in spleen size by palpation at end of cycle 6 (Time Frame - Up to end of Cycle 6 (each cycle is 28 days)):
Spleen response rate by palpation (RRP)

5. Durability of Spleen Volume Response by MRI/CT (DR) (Time Frame - Up to end of Cycle 6 (each cycle is 28 days)):
Is defined as time from the first documented spleen response (ie, ≥ 35% reduction in spleen volume) to the first documented spleen volume reduction < 35%.

6. Duration of ≥ 50 % reduction in spleen size by palpation for subjects with a palpable spleen at least 5 cm below the left costal margin (LCM) at baseline (Time Frame - Up to approximately 30 months):
From C1D1 until the 30- day follow-up after last dose visit

7. Duration of ≥ 50% reduction in total symptom scores measured by MFSAF (Time Frame - From enrollment until 30 days post last dose):
Durability of symptoms response (DSR)

8. Time from randomization to death due to any reason or disease progression (modified IWG-MRT 2013 including ≥ 25% increase in spleen volume by MRI/CT) (Time Frame - Up to 24 months from enrollment to End of Survival Follow-up):
Spleen and disease progression free survival (SDPFS)

9. Gastrointestinal Adverse Events (Time Frame - Up to approximately 30 months):
Incidence of subjects with Grade 3 or higher Gastrointestinal events (nausea, diarrhea, or vomiting) according to CTCAE v5.0

10. Encephalopathy Events, including Wernicke's (Time Frame - Up to 30 days post last dose):
Occurrence of confirmed encephalopathy events, including Wernicke's

11. Health-Related Quality of Life (HRQoL) (Time Frame - Up to 30-day follow-up after last dose visit):
To evaluate Health-Related Quality of Life (HRQoL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30)

12. EQ-5D-5L (Time Frame - Up to 20-day follow-up after last dose visit):
To evaluate Patient Reported Outcomes (PRO) as measured by the EQ-5D-5L questionnaire

13. Overall Survival (OS) (Time Frame - From randomization to the End of Survival Follow-up (approximately 12 months)):
Time from randomization to death due to any reason

Studien-Arme

  • Experimental: Fedratinib 400mg/day
    Will include up to 128 subjects receiving fedratinib 400 mg self-administered Investigational Product (IP) on an outpatient basis, once daily preferably together with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.
  • Active Comparator: Best Available Therapy (BAT)
    Best-available Investigator-selected therapy included a number of available compounds to treat MF and/or its symptoms and was chosen by the investigator for each subject. Therapy changed at different times during the treatment period. No investigational agents (e.g. not approved for the treatment of any indication) were allowed. BAT also included the choice of no treatment.

Geprüfte Regime

  • FEDRATINIB:
    A potent and selective inhibitor of JAK2 kinase activity
  • Best Available Therapy (BAT):
    Best available therapy (BAT)

Quelle: ClinicalTrials.gov


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