search
Back to results

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

Primary Purpose

Myelodysplastic Syndrome, MDS, Refractory Anemia With Excess Blasts

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rigosertib
Any approved or standard-of-care therapy
best supportive care (BSC)
best supportive care (BSC)
Sponsored by
Onconova Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic Syndrome, MDS

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • UC San Diego Moores Cancer Center
  • USC Norris Comprehensive Cancer Center
  • UCLA Medical Center
  • Cancer Specialists of North Florida
  • UF Health Shands Cancer Hospital
  • Mid Florida Hematology and Oncology Centers
  • Advanced Research Institute, Inc
  • Rush University Medical Center
  • University of Illinois Cancer Center
  • Loyola University Chicago at Loyola University Medical Center
  • Indiana University Health Hospital
  • The University of Kansas Cancer Center
  • Tulane Medical Center
  • University of Maryland Greenebaum Cancer Center
  • Tufts Medical Center
  • University of Minnesota Physicians Bone Marrow Transplant Clinic
  • Mayo Clinic
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • The Valley Hospital
  • Mount Sinai School of Medicine
  • Columbia University Medical Center
  • New York Medical College
  • Hospital of the University of Pennsylvania
  • Albert Einstein Medical Center, Cancer Center
  • Greenville Health System (GHS) Cancer Institute
  • UT Southwestern Medical Center
  • MD Anderson Cancer Center
  • Emily Couric Clinical Cancer Center
  • Seattle Cancer Care Alliance (SCCA)
  • University of Wisconsin Clinical Science Center
  • Marshfield Clinic - Marshfield Center
  • Icon Cancer Care Icon South Brisbane
  • Royal Hobart Hospital
  • Monash Health, Monash Medical Centre
  • Hospital of the Elisabethinen Linz GmbH
  • Salzburg University Hospital
  • Hanusch Hospital
  • Antwerp Hospital Network Stuivenberg
  • University Hospital Ghent
  • University Hospital Leuven, Campus Gasthuisberg
  • CHU UCL Namur - Site Godinne
  • CancerCare Manitoba
  • Sunnybrook Research Institute
  • Princess Margaret Cancer Centre
  • Jewish General Hospital
  • Klinički bolnički centar Osijek
  • Clinical Hospital Merkur
  • Klinički bolnicki centar Sestre milosrdnice
  • Klinički bolnički centar Zagreb
  • University Hospital Brno
  • University Hospital Hradec Kralove
  • University Hospital Ostrava, Department of Hematooncology
  • General University Hospital
  • Institute of Hematology and Blood Transfusion
  • North Estonia Medical Centre
  • Tartu University Hospital
  • CHD Vendée
  • Hôpital Claude Huriez, CHRU Lille
  • Institut Paoli-Calmettes
  • Hôpital l'Archet 1
  • Institut de Cancérologie du Gard
  • Hôpital Saint Louis
  • Centre Hospitalier Lyon-Sud
  • Hôpital civil, Strasbourg
  • CHRU Tours Hôspital Bretonneau
  • Universitätsklinikum Carl Gustav Carus
  • Marien Hospital Düsseldorf
  • Universitätsklinikum Frankfurt am Main
  • Semmelweis University Medical School
  • Somogy County Kaposi Mór Teaching Hospital
  • Jósa András Teaching Hospital
  • University of Pécs 1st Department of Internal Medicine
  • Hemato Oncology Clinic Pvt. Ltd
  • St. John's Medical College Hospital
  • Tata Memorial Hospital
  • Jaslok Hospital and Research Center
  • Sahyadri Clinical Research and Development Center
  • Christian Medical College
  • Institute Of Hematology And Transfusion Medicine
  • Cork University Hospital
  • Adelaide and Meath Hospital, Incorporating the National Children's Hospital
  • University Hospital Waterford
  • Ha'Emek Medical Center
  • Soroka University Medical Center
  • Rambam Medical Center
  • Hadassah Medical Center
  • Kaplan Medical Center
  • Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • Polyclinic S. Orsola-Malpighi
  • Azienda Ospedaliera Spedali Civili
  • Azienda Ospedaliero Universitaria Careggi
  • Azienda Ospedaliero-Universitaria Maggiore della Carità
  • A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa
  • Policlinico Universitario Tor Vergata
  • Ospedale S. Eugenio - S. Eugenio Hospital
  • Azienda Ospedaliera Santa Maria di Terni
  • Cittá della Salute e della Scienza di Torino
  • Kokura Memorial Hospital
  • Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
  • Sapporo Medical University Hospital
  • Kanazawa University Hospital
  • Yokohama City University Hospital
  • Shimane University Hospital
  • Japanese Red Cross Medical Center
  • Akita University Hospital
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Kagoshima University Hospital
  • Tokai Central Hospital of the Mutual Aid Association of Public School Teachers
  • Saitama Medical Center
  • Kobe City Hospital Organization Kobe City Medical Center General Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Japanese Red Cross Kyoto Daini Hospital
  • Nagasaki University Hospital
  • Japanese Red Cross Nagoya Daini Hospital
  • Niigata University Medical and Dental Hospital
  • Oita Prefectural Hospital
  • National Hospital Organization Okayama Medical Center
  • Kindai University Hospital
  • Hokkaido University Hospital
  • Tohoku University Hospital
  • NTT Medical Center Tokyo
  • Tokyo Medical University Hospital
  • Dokkyo Medical University Hospital
  • Tokushima University Hospital
  • Yamagata University Hospital
  • Saiseikai Yokohamashi Nanbu Hospital
  • University of Fukui Hospital
  • Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology
  • Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn
  • Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology
  • MTZ Clinical Research Sp. z o.o.
  • Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow
  • State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",
  • State Budgetary Healthcare Institution of Moscow City
  • FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency"
  • Hospital Son Llàtzer
  • Hospital Duran i Reynals - Instituto Catalán de Oncología
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Gregorio Marañón
  • Fundación Jiménez Díaz
  • Hospital Universitario Virgen de la Victoria
  • Hospital Universitario Salamanca
  • Hospital Universitari i Politècnic La Fe
  • Karolinska University Hospital
  • Skåne University Hospital, Department of Hematology
  • Uppsala University Hospital
  • Linköping University Hospital
  • University Hospital and University of Bern; Inselspital Bern
  • University Hospital Zurich
  • Royal Bournemouth Hospital
  • Aberdeen Royal Infirmary
  • The Royal Liverpool University Hospital
  • St Bartholomew's Hospital, Barts Health NHS Trust
  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rigosertib + best supportive care (BSC)

Physician's Choice (PC) + best supportive care (BSC)

Arm Description

Outcomes

Primary Outcome Measures

Overall survival of all randomized patients and overall survival of patients scored as IPSS-R very high risk.
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

Overall survival of patients with monosomy 7 chromosomal aberrations.
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.
Overall survival of patients with trisomy 8 chromosomal aberrations.
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.
Percent of patients with response according to 2006 IWG criteria.
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.
Scores of Quality of Life Questionnaire.
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.
Percent of patients with bone marrow blast response rate according to 2006 IWG criteria.
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.
Percent of patients with hematologic improvement (HI) (erythroid, platelet and neutrophil responses) according to 2006 IWG criteria.
Compare rigosertib vs PC in regard to the number and percent of patients who meet the 2006 IWG criteria.

Full Information

First Posted
September 25, 2015
Last Updated
September 22, 2022
Sponsor
Onconova Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02562443
Brief Title
Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA
Acronym
INSPIRE
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 Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Top line analysis indicated that the study had failed to achieve its primary endpoint.
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
July 26, 2020 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onconova Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome, MDS, Refractory Anemia With Excess Blasts, RAEB
Keywords
Myelodysplastic Syndrome, MDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rigosertib + best supportive care (BSC)
Arm Type
Experimental
Arm Title
Physician's Choice (PC) + best supportive care (BSC)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
rigosertib
Other Intervention Name(s)
ON 01910.Na
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Any approved or standard-of-care therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
best supportive care (BSC)
Intervention Description
Patients will receive best supportive care (BSC): azacitidine (AZA) and/or decitabine (DAC) are permitted.
Intervention Type
Drug
Intervention Name(s)
best supportive care (BSC)
Intervention Description
Patients will receive best supportive care (BSC).
Primary Outcome Measure Information:
Title
Overall survival of all randomized patients and overall survival of patients scored as IPSS-R very high risk.
Description
The overall survival (OS) of all randomized patients (ITT population), and the overall survival of patients scored as IPSS-R very high risk.
Time Frame
Up to 30 Months
Secondary Outcome Measure Information:
Title
Overall survival of patients with monosomy 7 chromosomal aberrations.
Description
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.
Time Frame
Up to 30 Months
Title
Overall survival of patients with trisomy 8 chromosomal aberrations.
Description
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.
Time Frame
Up to 30 Months
Title
Percent of patients with response according to 2006 IWG criteria.
Description
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.
Time Frame
Up to 30 Months
Title
Scores of Quality of Life Questionnaire.
Description
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.
Time Frame
At Baseline, at Week 4, Every 4 Weeks thereafter, and at the End-of-treatment.
Title
Percent of patients with bone marrow blast response rate according to 2006 IWG criteria.
Description
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.
Time Frame
Up to 30 Months
Title
Percent of patients with hematologic improvement (HI) (erythroid, platelet and neutrophil responses) according to 2006 IWG criteria.
Description
Compare rigosertib vs PC in regard to the number and percent of patients who meet the 2006 IWG criteria.
Time Frame
Up to 30 Months
Other Pre-specified Outcome Measures:
Title
Exploratory Objective: Bone Marrow Genomic Mutational Status
Description
Bone marrow genomic mutational status.
Time Frame
At screening, every 8 week during study treatment, and at the end of study treatment
Title
Exploratory Objective: Transition to Acute Myelogenous Leukemia (AML)
Description
Transformation time to AML (defined as a bone marrow or peripheral blood blast percentage >30%).
Time Frame
Through study completion, an average of 8 months
Title
Safety Objective: Number of Patients with AEs.
Description
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.
Time Frame
Monthly, through study completion
Title
Safety Objective: Rigosertib population pharmacokinetics (PK).
Description
Blood samples for population PK analysis will be taken in rigosertib patients
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Fruchtman, MD
Organizational Affiliation
Onconova Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Mid Florida Hematology and Oncology Centers
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Advanced Research Institute, Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Chicago at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Minnesota Physicians Bone Marrow Transplant Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Medical Center, Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Greenville Health System (GHS) Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9015
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Seattle Cancer Care Alliance (SCCA)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin Clinical Science Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Icon Cancer Care Icon South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Monash Health, Monash Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Hospital of the Elisabethinen Linz GmbH
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Salzburg University Hospital
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Antwerp Hospital Network Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL Namur - Site Godinne
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Klinički bolnički centar Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Clinical Hospital Merkur
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinički bolnicki centar Sestre milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinički bolnički centar Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Ostrava, Department of Hematooncology
City
Ostrava Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
General University Hospital
City
Prague 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Institute of Hematology and Blood Transfusion
City
Prague 2
ZIP/Postal Code
128 20
Country
Czechia
Facility Name
North Estonia Medical Centre
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
CHD Vendée
City
La Roche Sur Yon Cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
Hôpital Claude Huriez, CHRU Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hôpital l'Archet 1
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Institut de Cancérologie du Gard
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital civil, Strasbourg
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
CHRU Tours Hôspital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Marien Hospital Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Universitätsklinikum Frankfurt am Main
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Semmelweis University Medical School
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Somogy County Kaposi Mór Teaching Hospital
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Jósa András Teaching Hospital
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
University of Pécs 1st Department of Internal Medicine
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Hemato Oncology Clinic Pvt. Ltd
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
St. John's Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Jaslok Hospital and Research Center
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
Sahyadri Clinical Research and Development Center
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Institute Of Hematology And Transfusion Medicine
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Adelaide and Meath Hospital, Incorporating the National Children's Hospital
City
Dublin
ZIP/Postal Code
Dublin 24
Country
Ireland
Facility Name
University Hospital Waterford
City
Waterford
Country
Ireland
Facility Name
Ha'Emek Medical Center
City
'Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Polyclinic S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Universitario Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale S. Eugenio - S. Eugenio Hospital
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Cittá della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8556
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8544
Country
Japan
Facility Name
Tokai Central Hospital of the Mutual Aid Association of Public School Teachers
City
Kakamigahara
ZIP/Postal Code
504-8601
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center General Hospital
City
Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-008,
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daini Hospital
City
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8102
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya-shi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
ZIP/Postal Code
951-8510,
Country
Japan
Facility Name
Oita Prefectural Hospital
City
Oita
ZIP/Postal Code
870-8511
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital
City
Yokohama-shi
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology
City
Suwalki
ZIP/Postal Code
16-400
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warsaw
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow City
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency"
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Duran i Reynals - Instituto Catalán de Oncología
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karolinska University Hospital
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
141 57
Country
Sweden
Facility Name
Skåne University Hospital, Department of Hematology
City
Lund
ZIP/Postal Code
222 82
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 81
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
University Hospital and University of Bern; Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
The Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
St Bartholomew's Hospital, Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26968357
Citation
Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.
Results Reference
background
PubMed Identifier
27104980
Citation
Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.
Results Reference
background
PubMed Identifier
27400247
Citation
Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15.
Results Reference
background
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs