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Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (INSPIRE)

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ClinicalTrials.gov Identifier: NCT02562443
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Onconova Therapeutics, Inc.

Brief Summary:
The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome MDS Refractory Anemia With Excess Blasts RAEB Drug: rigosertib Drug: Any approved or standard-of-care therapy Drug: best supportive care (BSC) Phase 3

Detailed Description:

This is a Phase III, open-label, randomized, controlled, international study. Approximately 360 patients < 82 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DAC for ≤ 9 months and/or ≤ 9 cycles over 12 months and had their last dose of AZA or DAC within 6 months prior to screening will be stratified by:

  • Very high risk (VHR) vs non-VHR per IPSS-R, and
  • Geographic region (North America vs Europe vs Asia; because approved products and standard of care may vary by region), and randomly assigned in a 2:1 ratio to one of the following 2 treatment groups:
  • Rigosertib 1800 mg/24 hr administered as a 72 hr CIV infusion on Days 1, 2, and 3 of a 2 week cycle for the first 8 cycles, and on Days 1, 2, and 3 of a 4-week cycle thereafter (N = approximately 240 patients);
  • Physician's Choice of alternative treatment, which may include any approved or standard-of-care therapy that the patient has not shown to be hypersensitive to, based on frequently used treatment for MDS, as per institutional guidelines, after receipt of HMAs (N = approximately 120 patients). The drugs used in the Physician's Choice arm should be used according to the recommendations, if clinically appropriate, provided in the corresponding Summary of Product Characteristics (SmPC) and Prescribing Information of these drugs. Experimental therapies are not allowed on the PC arm.

Patients will be treated until 2006 IWG progression criteria are met (ie, 50% increase of BM blasts or worsening of cytopenias) or until an unacceptable toxicity or intolerance.

For all randomized patients who discontinue study treatment, subsequent therapies with their start and end dates, as well as survival time after treatment discontinuation, will be documented at least monthly until death.

Patients in the PC group who progress will not be allowed to cross over to rigosertib.

All patients in both treatment groups will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (granulocyte colony-stimulating factor (G-CSF), erythropoietin, and thrombopoietin).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent
Study Start Date : October 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: rigosertib + best supportive care (BSC) Drug: rigosertib
Patients will receive intravenous rigosertib 1800 mg/24 hr for 3 days every 2 weeks for first 8 cycles, then every 4 weeks thereafter + best supportive care (BSC).
Other Name: ON 01910.Na

Drug: best supportive care (BSC)
Patients will receive best supportive care (BSC).

Active Comparator: Physician's Choice (PC) + best supportive care (BSC) Drug: Any approved or standard-of-care therapy
Patients will receive Physician's Choice of Treatment or alternative treatment which may include any approved or standard-of-care therapy, based on frequently used treatment for MDS (no experimental therapy) + best supportive care.

Drug: best supportive care (BSC)
Patients will receive best supportive care (BSC): azacitidine (AZA) and/or decitabine (DAC) are permitted.




Primary Outcome Measures :
  1. Overall survival of all randomized patients and overall survival of patients scored as IPSS-R very high risk. [ Time Frame: Up to 30 Months ]
    The overall survival (OS) of all randomized patients (ITT population), and the overall survival of patients scored as IPSS-R very high risk.


Secondary Outcome Measures :
  1. Overall survival of patients with monosomy 7 chromosomal aberrations. [ Time Frame: Up to 30 Months ]
    Evaluate OS of patients with monosomy 7 chromosomal aberrations in the rigosertib vs PC group. Overall survival is the time (months) from date of randomization to date of death or date last known to be alive at the time of date cut-off.

  2. Overall survival of patients with trisomy 8 chromosomal aberrations. [ Time Frame: Up to 30 Months ]
    Evaluate OS of patients with trisomy 8 chromosomal aberrations in the rigosertib vs PC group. Overall survival is the time (months) from date of randomization to date of death or date last known to be alive at the time of date cut-off.

  3. Percent of patients with response according to 2006 IWG criteria. [ Time Frame: Up to 30 Months ]
    Responses of complete remission (CR), partial remission (PR), mCR, SD, failure, and PD will be determined by 2006 IWG criteria. The number and percent of patients with CR, PR, mCR, SD, Failure, or PD will be summarized by treatment group.

  4. Scores of Quality of Life Questionnaire. [ Time Frame: At Baseline, at Week 4, Every 4 Weeks thereafter, and at the End-of-treatment. ]
    Compare rigosertib vs PC in regard to the the scores of the EuroQol EQ-5D-5L Questionnaire. The EuroQol EQ-5D-5L Questionnaire includes five levels of severity in each of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a visual analogue scale.

  5. Percent of patients with bone marrow blast response rate according to 2006 IWG criteria. [ Time Frame: Up to 30 Months ]
    Compare rigosertib vs PC in regard to the bone marrow blast responses of marrow complete response (mCR ≥ 50% decrease of BMBL vs pretreatment values to a value ≤ 5%), marrow partial response (mPR, ≥ 50% decrease of BMBL vs pretreatment values to a value > 5%), stable disease (SD, no mCR or mPR, but no progressive disease (PD), and PD (≥ 50% BMBL increase relative to baseline or nadir) will be assessed. The number and percent of patients with mCR, mPR, SD, or PD will be summarized by treatment group. Responses of complete remission (CR), partial remission (PR), mCR, SD, failure, and PD will be determined by 2006 International Working Group (IWG) criteria.

  6. Percent of patients with hematologic improvement (HI) (erythroid, platelet and neutrophil responses) according to 2006 IWG criteria. [ Time Frame: Up to 30 Months ]
    Compare rigosertib vs PC in regard to the number and percent of patients who meet the 2006 IWG criteria.


Other Outcome Measures:
  1. Exploratory Objective: Bone Marrow Genomic Mutational Status [ Time Frame: At screening, every 8 week during study treatment, and at the end of study treatment ]
    Bone marrow genomic mutational status.

  2. Exploratory Objective: Transition to Acute Myelogenous Leukemia (AML) [ Time Frame: Through study completion, an average of 8 months ]
    Transformation time to AML (defined as a bone marrow or peripheral blood blast percentage >30%).

  3. Safety Objective: Number of Patients with AEs. [ Time Frame: Monthly, through study completion ]
    Treatment-emergent adverse events (TEAEs) will be graded according to NCI CTCAE version 4, grouped by MedDRA preferred term, and summarized by worst grade of severity per patient by treatment group.

  4. Safety Objective: Rigosertib population pharmacokinetics (PK). [ Time Frame: At Cycle 1 (Week 1) and Cycle 2 (Week 3), on Day 1 of the infusion, 1 hr after its start and on Day 2 of the infusion, 6 hr after its start ]
    Blood samples for population PK analysis will be taken in rigosertib patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MDS classified as follows:

    • RAEB-1 per World Health Organization (WHO) MDS criteria (5% to <10% BM blasts)
    • RAEB-2 per WHO MDS criteria (10% to <20% BM blasts)
    • RAEB-t per French-American-British (FAB) classification (20% to 30% BM blasts)
  • At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL)
  • Progression (according to 2006 IWG criteria) at any time after initiation of AZA or DAC treatment or Failure to achieve complete or partial response or hematological improvement (HI) (according to 2006 IWG) after at least six 4-week cycles of AZA or either four 4-week or four 6-week cycles of DAC administered or Relapse after initial complete or partial response or HI (according to 2006 IWG criteria)
  • Duration of prior HMA therapy ≤ 9 months and/or total ≤ 9 cycles of prior HMA therapy in ≤ 12 months
  • Last dose of AZA or DAC within 6 months before the planned date of randomization; however, must be off these treatments for ≥ 4 weeks before randomization
  • Has failed to respond to, relapsed following, not eligible for, or opted not to participate in allogeneic stem cell transplantation
  • Off all treatments for MDS (including AZA and DAC) for ≥ 4 weeks before randomization; growth factors (G-CSF, erythropoietin and thrombopoietin) and transfusions are allowed before and during the study as clinically indicated
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Willing to adhere to protocol prohibitions and restrictions
  • Patient must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate. Should patient be incapable of giving consent, the patient's legally authorized representative (as defined by local regulation) must give consent. However, should patient, in any manner, choose not to participate this takes precedence and will be respected.
  • Patients with 5q- syndrome should have failed to respond to or progressed on treatment with lenalidomide, where available and indicated

Exclusion Criteria:

  • Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening for other rigosertib studies may be screened for participation
  • Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabine
  • Suitable candidate to receive allogeneic stem cell transplantation; patient is eligible for study if a suitable candidate refuses to undergo an allogeneic stem cell transplant or a suitable donor cannot be found
  • Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ that is unlikely to progress in two years
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure or unstable angina pectoris
  • Active infection not adequately responding to appropriate therapy
  • Total bilirubin ≥1.5 mg/dL not related to hemolysis or Gilbert's disease
  • Alanine transaminase (ALT)/aspartate transaminase (AST) ≥2.5 x upper limit of normal (ULN)
  • Serum creatinine ≥2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) < 40 mL/min.
  • Known active HIV, hepatitis B or hepatitis C, where active is defined as follows:

    • HIV or hepatitis C - presence of viral load
    • Hepatitis B - antigen positive
  • Uncorrected hyponatremia (defined as serum sodium value of <130 mEq/L)
  • Female patients of child-bearing potential and male patients with sexual partners of child-bearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the 30-day non-treatment follow-up period. Examples of acceptable contraception methods include:

    • estrogen-gestagen based contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal),
    • gestagen-only based contraceptives associated with inhibition of ovulation (oral, injectable, implantable),
    • intra-uterine devices (IUDs),
    • intra-uterine hormone-releasing systems (IUSs),
    • bilateral tubal occlusion
    • vasectomized partner
    • sexual abstinence in accordance with an individual's lifestyle
  • Female patients of child-bearing potential (pre-menopausal and not surgically sterilized) who are breast-feeding or have a positive blood beta-human chorionic gonadotropin pregnancy test at Screening
  • Major surgery without full recovery or within 3 weeks before planned randomization;
  • Uncontrolled hypertension
  • New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
  • Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or corticosteroids (prednisone up to 20 mg/day or its equivalent is permitted for chronic conditions)
  • Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the treatment of MDS (other than growth factors and other supportive care measures) within 4 weeks of planned randomization
  • Investigational therapy within 4 weeks of planned randomization
  • Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
  • Patient previously diagnosed with AML (defined as a bone marrow or peripheral blood blast percentage of >30%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562443


Contacts
Layout table for location contacts
Contact: Joseph Morgan, MD (267) 759-3680 jmorgan@onconova.us
Contact: Steven M Fruchtman, MD (267) 759-3680 sfruchtman@onconova.us

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Locations
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United States, California
UC San Diego Moores Cancer Center Terminated
La Jolla, California, United States, 92093
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Casey O'Connell, MD         
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Gary J. Schiller, MD         
United States, Connecticut
Cancer Center of Central Connecticut Recruiting
Plainville, Connecticut, United States, 06062
Principal Investigator: Wylie D. Hosmer, MD         
United States, Florida
Cancer Specialists of North Florida Recruiting
Fleming Island, Florida, United States, 32003
Principal Investigator: Mehdi Moezi, MD         
UF Health Shands Cancer Hospital Recruiting
Gainesville, Florida, United States, 32608
Principal Investigator: Christopher R. Cogle, MD         
Mid Florida Hematology and Oncology Centers Recruiting
Orange City, Florida, United States, 32763
Principal Investigator: Santosh Nair, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Jamile Shammo, MD         
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Irum Khan, MD         
The University of Chicago Medical Center Withdrawn
Chicago, Illinois, United States, 60637
Loyola University Chicago at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Principal Investigator: Patrick J. Stiff, MD         
United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: S. Hamid Sayar, MD         
United States, Kansas
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Principal Investigator: Abdulraheem M. Yacoub, MD         
United States, Louisiana
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Hana Safah, MD         
United States, Maryland
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Maria R. Baer, MD         
Center for Cancer and Blood Disorders (Regional Cancer Care Associates LLC) Withdrawn
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Kellie Sprague, MD         
United States, Michigan
Henry Ford Hospital Withdrawn
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Physicians Bone Marrow Transplant Clinic Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Erica Warlick, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Aref Al-Kali, MD         
United States, New Jersey
Hunterdon Medical Center Withdrawn
Flemington, New Jersey, United States, 08822
John Theurer Cancer Center at Hackensack University Medical Center Terminated
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Principal Investigator: Dale Schaar, MD, PhD         
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Principal Investigator: Jason Suh, MD         
United States, New Mexico
The University of New Mexico Comprehensive Cancer Center Withdrawn
Albuquerque, New Mexico, United States, 87131
United States, New York
Northwell Health Withdrawn
Lake Success, New York, United States, 11042
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: Lewis R. Silverman, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Mark Heaney, MD         
New York Presbyterian Hospital - Weill Cornell Medical Center Withdrawn
New York, New York, United States, 10065
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Principal Investigator: Karen Seiter, MD         
United States, Pennsylvania
Lancaster Cancer Center Withdrawn
Lancaster, Pennsylvania, United States, 17605
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Selina Luger, MD         
Albert Einstein Medical Center, Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Principal Investigator: Claudia M. Dourado, MD         
United States, South Carolina
Greenville Health System (GHS) Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Principal Investigator: Suzanne R. Fanning, DO         
United States, Texas
Texas Oncology-Medical City Dallas Withdrawn
Dallas, Texas, United States, 75230
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9015
Principal Investigator: Prapti Patel, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Guillermo Garcia-Manero, MD         
United States, Utah
Northern Utah Associates Withdrawn
Ogden, Utah, United States, 84403
United States, Virginia
Emily Couric Clinical Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Principal Investigator: Michael Keng, MD         
United States, Washington
Seattle Cancer Care Alliance (SCCA) Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Bart Scott, MD         
United States, Wisconsin
University of Wisconsin Clinical Science Center Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Ryan Mattison, MD         
Marshfield Clinic - Marshfield Center Terminated
Marshfield, Wisconsin, United States, 54449
Australia, New South Wales
St Vincent's Hospital Sydney Withdrawn
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Icon Cancer Care Icon South Brisbane Recruiting
South Brisbane, Queensland, Australia, 4101
Principal Investigator: Simon Durrant         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Principal Investigator: Rosemary Anne Harrup, MD         
Australia, Victoria
Peninsula and South Eastern Hematology and Oncology Group Withdrawn
Frankston, Victoria, Australia, 3199
Monash Health, Monash Medical Centre Recruiting
Melbourne, Victoria, Australia, 3168
Principal Investigator: Jake Shortt, MD, PhD         
Austria
Hospital of the Elisabethinen Linz GmbH Recruiting
Linz, Austria, 4020
Principal Investigator: Sigrid Machherndl-Spandl, MD         
Salzburg University Hospital Recruiting
Salzburg, Austria, 5020
Principal Investigator: Richard Greil, MD         
Hanusch Hospital Recruiting
Vienna, Austria, 1140
Principal Investigator: Michael Pfeilstöcker, MD         
Belgium
Antwerp Hospital Network Stuivenberg Recruiting
Antwerp, Belgium, 2060
Principal Investigator: Dimitri Breems, MD         
General Hospital Saint-Jan Recruiting
Brugge, Belgium, 8000
Principal Investigator: Dominik Selleslag         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Dominiek Mazure, MD         
University Hospital Leuven, Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Principal Investigator: Mariëlle Beckers, PhD         
CHU UCL Namur - Site Godinne Recruiting
Yvoir, Belgium, B-5530
Principal Investigator: Carlos Graux, MD         
Canada, Alberta
University of Alberta Hospital Withdrawn
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Principal Investigator: Emily Rimmer, MD         
Canada, Ontario
Juravinski Cancer Centre Withdrawn
Hamilton, Ontario, Canada, L8V 5C2
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Rena Buckstein, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Karen Yee, MD         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: Sarit Assouline, MD         
Croatia
Klinički bolnički centar Osijek Recruiting
Osijek, Croatia, 31000
Principal Investigator: Jasminka Sinčić Petričević, MD         
Clinical Hospital Merkur Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Inga Mandac Rogulj, MD         
Klinički bolnicki centar Sestre milosrdnice Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Petar Gaćina, MD, PhD         
Klinički bolnički centar Zagreb Recruiting
Zagreb, Croatia, 10000
Principal Investigator: Nadira Duraković, MD, PhD         
Czechia
University Hospital Brno Recruiting
Brno, Czechia, 625 00
Principal Investigator: Jiří Mayer, MD, PhD         
University Hospital Hradec Kralove Recruiting
Hradec Kralove, Czechia, 500 05
Principal Investigator: Petra Belohlavkova, MD         
University Hospital Ostrava, Department of Hematooncology Recruiting
Ostrava Poruba, Czechia, 708 52
Principal Investigator: Roman Hajek         
General University Hospital Recruiting
Prague 2, Czechia, 128 00
Principal Investigator: Anna Jonasova, MD         
Institute of Hematology and Blood Transfusion Recruiting
Prague 2, Czechia, 128 20
Principal Investigator: Jaroslav Cermak, MD, PhD         
Estonia
North Estonia Medical Centre Recruiting
Tallinn, Estonia, 13419
Principal Investigator: Iige Viigimaa         
Tartu University Hospital Recruiting
Tartu, Estonia, 51014
Principal Investigator: Jane Lehtmaa, MD         
France
CHD Vendée Recruiting
La Roche Sur Yon Cedex 9, France, 85925
Principal Investigator: Bruno Villemagne, MD         
Hôpital Claude Huriez, CHRU Lille Recruiting
Lille Cedex, France, 59037
Principal Investigator: Bruno Quesnel, MD, PhD         
Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Principal Investigator: Norbert Vey, MD         
Hôpital l'Archet 1 Recruiting
Nice Cedex 3, France, 06202
Principal Investigator: Laurence Legros, MD         
Institut de Cancérologie du Gard Recruiting
Nimes Cedex 9, France, 30029
Principal Investigator: Eric Jourdan, MD, PhD         
Hôpital Saint Louis Recruiting
Paris Cedex 10, France, 75475
Principal Investigator: Pierre Fenaux, MD, PhD         
Centre Hospitalier Lyon-Sud Recruiting
Pierre-Bénite, France, 69495
Principal Investigator: Eric Wattel, MD, PhD         
Hôpital civil, Strasbourg Recruiting
Strasbourg Cedex, France, 67091
Principal Investigator: Shanti Natarajan-Amé, MD         
CHRU Tours Hôspital Bretonneau Recruiting
Tours, France, 37044
Principal Investigator: Emmanual Gyan, MD, PhD         
Germany
St. Hedwig-Krankenhaus; Poliklinik Withdrawn
Berlin, Germany, 10115
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Principal Investigator: Uwe Platzbecker, MD         
Marien Hospital Düsseldorf Recruiting
Düsseldorf, Germany, 40479
Principal Investigator: Aristoteles Giagounidis, MD         
Universitätsklinikum Essen Withdrawn
Essen, Germany, 45147
Universitätsklinikum Frankfurt am Main Recruiting
Frankfurt, Germany, 60590
Principal Investigator: Jörg Chromik, MD         
Universitätsmedizin Göttingen Withdrawn
Göttingen, Germany, 37075
Klinikum rechts der Isar der TU München Withdrawn
Munich, Germany, 81675
Rems-Murr-Klinikum Winnenden Withdrawn
Winnenden, Germany, 71364
Hungary
Semmelweis University Medical School Recruiting
Budapest, Hungary, 1083
Principal Investigator: Judit Demeter, MD, PhD, DSc         
Somogy County Kaposi Mór Teaching Hospital Recruiting
Kaposvár, Hungary, 7400
Principal Investigator: Miklós Egyed, MD, PhD         
Jósa András Teaching Hospital Recruiting
Nyíregyháza, Hungary, 4400
Principal Investigator: László Rejtő         
University of Pécs 1st Department of Internal Medicine Recruiting
Pécs, Hungary, 7624
Principal Investigator: Hussain Alizadeh, MD         
India
Hemato Oncology Clinic Pvt. Ltd Recruiting
Ahmedabad, Gujarat, India, 380009
Principal Investigator: Sandip A. Shah, MD         
Jaslok Hospital and Research Center Recruiting
Mumbai, Maharashtra, India, 400026
Principal Investigator: Advani S Hariram, MD         
Sahyadri Clinical Research and Development Center Recruiting
Pune, Maharashtra, India, 411004
Principal Investigator: Kannan Subramanian, MBBS         
Christian Medical College Recruiting
Vellore, Tamil Nadu, India, 632004
Principal Investigator: Biju George, MD         
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Principal Investigator: Mary Rose Cahill, MD, PhD         
Adelaide and Meath Hospital, Incorporating the National Children's Hospital Recruiting
Dublin, Ireland, Dublin 24
Principal Investigator: Helen Enright, MD         
University Hospital Galway Withdrawn
Galway, Ireland
University Hospital Waterford Recruiting
Waterford, Ireland
Principal Investigator: Senthil Kumar         
Israel
Ha'Emek Medical Center Recruiting
'Afula, Israel, 1834111
Principal Investigator: Galia Bartfeld-Stemer, MD         
Barzilai Medical Center Withdrawn
Ashkelon, Israel, 7830604
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Principal Investigator: Itai Levi, MD         
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Principal Investigator: Yishai Ofran, MD         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Dina Ben-Yehuda,, MD         
Galilee Medical Center Withdrawn
Nahariya, Israel, 2210001
Rabin Medical Center Withdrawn
Petah Tikva, Israel, 49100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Principal Investigator: Kalman Filanovsky, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Principal Investigator: Moshe Mittelman, MD         
The Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Derorit Merkel, MD         
Italy
Polyclinic S. Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Principal Investigator: Michele Cavo         
Azienda Ospedaliera Spedali Civili Recruiting
Brescia, Italy, 25123
Principal Investigator: Giuseppe Rossi, MD         
Azienda Ospedaliero Universitaria Careggi Recruiting
Firenze, Italy, 50134
Principal Investigator: Valeria Santini, MD         
Azienda Ospedaliero-Universitaria Maggiore della Carità Recruiting
Novara, Italy, 28100
Principal Investigator: Monia Lunghi, MD, PhD         
A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa Recruiting
Pisa, Italy, 56126
Principal Investigator: Mario Petrini, MD         
Policlinico Universitario Tor Vergata Recruiting
Roma, Italy, 00133
Principal Investigator: Maria Teresa Voso, MD         
Ospedale S. Eugenio - S. Eugenio Hospital Recruiting
Roma, Italy, 00144
Principal Investigator: Pasquale Niscola, MD         
Azienda Ospedaliera Santa Maria di Terni Recruiting
Terni, Italy, 05100
Principal Investigator: Anna Marina Liberati, MD         
Cittá della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Principal Investigator: Dario Ferrero, MD         
Japan
Kokura Memorial Hospital Recruiting
Kitakyushu, Fukuoka, Japan, 802-8555
Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers Recruiting
Fukuyama, Hiroshima, Japan, 720-0001
Sapporo Medical University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8556
Kanazawa University Hospital Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Yokohama City University Hospital Recruiting
Yokohama-shi, Kanagawa, Japan, 236-0004
Shimane University Hospital Recruiting
Izumo, Shimane, Japan, 693-8501
Japanese Red Cross Medical Center Recruiting
Shibuya, Tokyo, Japan, 150-8935
Akita University Hospital Recruiting
Akita, Japan, 010-8543
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Recruiting
Bunkyo-ku, Japan, 113-8677
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka-shi, Japan, 811-1395
Fukuoka University Hospital Withdrawn
Fukuoka-shi, Japan, 814-0180
Kagoshima University Hospital Recruiting
Kagoshima, Japan, 890-8544
Tokai Central Hospital of the Mutual Aid Association of Public School Teachers Recruiting
Kakamigahara, Japan, 504-8601
Saitama Medical Center Recruiting
Kawagoe, Japan, 350-8550
Kobe City Hospital Organization Kobe City Medical Center General Hospital Recruiting
Kobe, Japan, 650-0047
National Hospital Organization Kumamoto Medical Center Recruiting
Kumamoto, Japan, 860-008,
Japanese Red Cross Kyoto Daini Hospital Recruiting
Kyoto, Japan, 602-8026
Gunma University Hospital Withdrawn
Maebashi, Japan, 371-8511,
Nagasaki University Hospital Recruiting
Nagasaki, Japan, 852-8102
Japanese Red Cross Nagoya Daini Hospital Recruiting
Nagoya-shi, Japan, 466-8650
Niigata University Medical and Dental Hospital Recruiting
Niigata, Japan, 951-8510,
Oita Prefectural Hospital Recruiting
Oita, Japan, 870-8511
National Hospital Organization Okayama Medical Center Recruiting
Okayama, Japan, 701-1192
Kindai University Hospital Recruiting
Osakasayama-shi, Japan, 589-8511
Hokkaido University Hospital Recruiting
Sapporo-shi, Japan, 060-8648
Tohoku University Hospital Recruiting
Sendai-shi, Japan, 980-8574
NTT Medical Center Tokyo Recruiting
Shinagawa-ku, Japan, 141-8625
Tokyo Medical University Hospital Recruiting
Shinjuku-ku, Japan, 160-0023
Dokkyo Medical University Hospital Recruiting
Tochigi, Japan, 321-0293
Tokushima University Hospital Recruiting
Tokushima, Japan, 770-8503
Yamagata University Hospital Recruiting
Yamagata, Japan, 990-9585
Saiseikai Yokohamashi Nanbu Hospital Recruiting
Yokohama-shi, Japan, 234-8503
University of Fukui Hospital Recruiting
Yoshida, Japan, 910-1193
Netherlands
VU University Medical Center Withdrawn
Amsterdam, Netherlands, 1081 HV
Poland
University Hospital in Bialystok Withdrawn
Bialystok, Poland, 15-276
Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology Recruiting
Kraków, Poland, 31-501
Principal Investigator: Dorota Krochmalczyk, MD, PhD         
Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn Recruiting
Olsztyn, Poland, 10-228
Principal Investigator: Wanda Knopińska-Posluszny, MD, PhD         
Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology Recruiting
Suwalki, Poland, 16-400
Principal Investigator: Alina Urbanowicz         
MTZ Clinical Research Sp. z o.o. Recruiting
Warsaw, Poland, 02-106
Principal Investigator: Wieslaw Jedrzejczak, MD         
Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow Recruiting
Wroclaw, Poland, 50-367
Principal Investigator: Tomasz Wróbel, MD, PhD         
Russian Federation
State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev", Recruiting
Kemerovo, Russian Federation, 650066
Principal Investigator: Marina Kosinova, MD         
State Budgetary Healthcare Institution of Moscow City Recruiting
Moscow, Russian Federation, 129301
Principal Investigator: Vadim Doronin, MD         
FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency" Recruiting
Saint Petersburg, Russian Federation, 191024
Principal Investigator: Sergey V, Gritsaev, MD, PhD         
Spain
Hospital Son Llàtzer Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07198
Principal Investigator: Joan Bargay-Lleonart, MD         
Hospital Duran i Reynals - Instituto Catalán de Oncología Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08908
Principal Investigator: Montserrat Arnan Sangerman, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: David Valcárcel Ferreiras, MD, PhD         
Hospital Universitari Germans Trias i Pujol Recruiting
Barcelona, Spain, 08916
Principal Investigator: Blanca Xicoy Cirici, MD         
Complejo Asistencial Universitario de León Withdrawn
León, Spain, 24071
Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Principal Investigator: Patricia Font López, MD         
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Principal Investigator: Maria Ángeles Pérez Sáenz, MD, PhD         
Hospital Universitario Virgen de la Arrixaca Withdrawn
Murcia, Spain, 30120
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Principal Investigator: Ana-Isabel Rosell-Mas, MD         
Complejo Hospitalario de Navarra Withdrawn
Pamplona, Spain, 31008
Hospital Universitario Salamanca Recruiting
Salamanca, Spain, 37007
Principal Investigator: María Díez Campelo, MD, PhD         
Hospital Universitario Virgen del Rocío Withdrawn
Sevilla, Spain, 41013
Hospital Universitari i Politècnic La Fe Recruiting
Valencia, Spain, 46026
Principal Investigator: Guillermo Sanz-Santillana, MD         
Sweden
Karolinska University Hospital Recruiting
Stockholm, Huddinge, Sweden, 141 57
Principal Investigator: Per Anders MD Broliden, MD         
Skåne University Hospital, Department of Hematology Recruiting
Lund, Sweden, 222 82
Principal Investigator: Lars Nilsson, MD         
Uppsala University Hospital Recruiting
Uppsala, Sweden, 751 81
Principal Investigator: Elisabeth Ejerblad, MD, PhD         
Linköping University Hospital Recruiting
Linköping, Östergötland, Sweden, 581 85
Principal Investigator: Petar Antunovic, MD         
Switzerland
University Hospital and University of Bern; Inselspital Bern Recruiting
Bern, Switzerland, 3010
Principal Investigator: Nicolas Bonadies, MD         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Principal Investigator: Stefan Balabanov, MD         
United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, Dorset, United Kingdom, BH7 7DW
Principal Investigator: Sally B. Killick, MD         
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Principal Investigator: Dominic J. Culligan, MD         
The Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Principal Investigator: Rahuman Salim         
St Bartholomew's Hospital, Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Principal Investigator: James D. Cavenagh, MD         
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Ghulam J Mufti         
Sponsors and Collaborators
Onconova Therapeutics, Inc.
Investigators
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Study Chair: Steven M. Fruchtman, MD Onconova Therapeutics, Inc.

Publications of Results:
Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

Other Publications:
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Responsible Party: Onconova Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02562443     History of Changes
Other Study ID Numbers: Onconova 04-30
2015-001476-22 ( EudraCT Number )
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Onconova Therapeutics, Inc.:
Myelodysplastic Syndrome
MDS
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Anemia
ON 01910
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action