AzTrials
AzTrials

Myelodysplastic SyndromePhase 3INSPIRENCT02562443

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

A Phase 3 study testing rigosertib and Any approved or standard-of-care therapy in people with Myelodysplastic Syndrome and MDS, run by Traws Pharma, Inc. at 158 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 81 years
What is being tested?
rigosertib and Any approved or standard-of-care therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
158 sitesin 22 countries
Study dates
2 Dec 2015to 26 Jul 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

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

  • Ages 18 to 81 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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%).

Trial locations and contacts

158 sites in 22 countries.

158 sites in 22 countries

United States32 sites

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22903

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9015

  • Cancer Specialists of North Florida

    Fleming Island, Florida, 32003

  • UF Health Shands Cancer Hospital

    Gainesville, Florida, 32608

  • Greenville Health System (GHS) Cancer Institute

    Greenville, South Carolina, 29605

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Loyola University Chicago at Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Minnesota Physicians Bone Marrow Transplant Clinic

    Minneapolis, Minnesota, 55455

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Mid Florida Hematology and Oncology Centers

    Orange City, Florida, 32763

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Albert Einstein Medical Center, Cancer Center

    Philadelphia, Pennsylvania, 19141

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Seattle Cancer Care Alliance (SCCA)

    Seattle, Washington, 98109

  • Advanced Research Institute, Inc

    St. Petersburg, Florida, 33710

  • New York Medical College

    Valhalla, New York, 10595

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

Japan31 sites

  • Akita University Hospital

    Akita, 010-8543

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City, 113-8677

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers

    Fukuyama, Hiroshima, 720-0001

  • Shimane University Hospital

    Izumo, Shimane, 693-8501

  • Kagoshima University Hospital

    Kagoshima, 890-8544

  • Tokai Central Hospital of the Mutual Aid Association of Public School Teachers

    Kakamigahara, 504-8601

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Saitama Medical Center

    Kawagoe, 350-8550

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-008,

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, 602-8026

  • Nagasaki University Hospital

    Nagasaki, 852-8102

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 466-8650

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8510,

  • Oita Prefectural Hospital

    Ōita, 870-8511

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Kindai University Hospital

    Osakasayama-shi, 589-8511

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8556

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, 980-8574

  • Japanese Red Cross Medical Center

    Shibuya City, Tokyo, 150-8935

  • NTT Medical Center Tokyo

    Shinagawa-ku, 141-8625

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • Dokkyo Medical University Hospital

    Tochigi, 321-0293

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, 234-8503

  • University of Fukui Hospital

    Yoshida, 910-1193

Other trials in Japan

France9 sites

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Hôpital Claude Huriez, CHRU Lille

    Lille, 59037

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Hôpital l'Archet 1

    Nice, 06202

  • Institut de Cancérologie du Gard

    Nîmes, 30029

  • Hôpital Saint Louis

    Paris, 75475

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Hôpital civil, Strasbourg

    Strasbourg, 67091

  • CHRU Tours Hôspital Bretonneau

    Tours, 37044

Other trials in France

Italy9 sites

  • Polyclinic S. Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Spedali Civili

    Brescia, 25123

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Azienda Ospedaliero-Universitaria Maggiore della Carità

    Novara, 28100

  • A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa

    Pisa, 56126

  • Policlinico Universitario Tor Vergata

    Roma, 00133

  • Ospedale S. Eugenio - S. Eugenio Hospital

    Roma, 00144

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, 05100

  • Cittá della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Spain9 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Duran i Reynals - Instituto Catalán de Oncología

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Son Llàtzer

    Palma de Mallorca, Balearic Islands, 07198

  • Hospital Universitario Salamanca

    Salamanca, 37007

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

India7 sites

  • Hemato Oncology Clinic Pvt. Ltd

    Ahmedabad, Gujarat, 380009

  • St. John's Medical College Hospital

    Bangalore, Karnataka, 560034

  • Institute Of Hematology And Transfusion Medicine

    Kolkata, West Bengal, 700073

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • Jaslok Hospital and Research Center

    Mumbai, Maharashtra, 400026

  • Sahyadri Clinical Research and Development Center

    Pune, Maharashtra, 411004

  • Christian Medical College

    Vellore, Tamil Nadu, 632004

Other trials in India

Israel7 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Medical Center

    Jerusalem, 91120

  • Kaplan Medical Center

    Rehovot, 76100

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Czechia5 sites

  • University Hospital Brno

    Brno, 625 00

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Ostrava, Department of Hematooncology

    Ostrava Poruba, 708 52

  • General University Hospital

    Prague, 128 00

  • Institute of Hematology and Blood Transfusion

    Prague, 128 20

Other trials in Czechia

Poland5 sites

  • Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology

    Krakow, 31-501

  • Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn

    Olsztyn, 10-228

  • Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology

    Suwałki, 16-400

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-106

  • Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow

    Wroclaw, 50-367

Other trials in Poland

United Kingdom5 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • The Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • St Bartholomew's Hospital, Barts Health NHS Trust

    London, EC1A 7BE

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

Other trials in United Kingdom

Belgium4 sites

  • Antwerp Hospital Network Stuivenberg

    Antwerp, 2060

  • University Hospital Ghent

    Ghent, 9000

  • University Hospital Leuven, Campus Gasthuisberg

    Leuven, 3000

  • CHU UCL Namur - Site Godinne

    Yvoir, B-5530

Other trials in Belgium

Canada4 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Croatia4 sites

  • Klinički bolnički centar Osijek

    Osijek, 31000

  • Clinical Hospital Merkur

    Zagreb, 10000

  • Klinički bolnicki centar Sestre milosrdnice

    Zagreb, 10000

  • Klinički bolnički centar Zagreb

    Zagreb, 10000

Other trials in Croatia

Hungary4 sites

  • Semmelweis University Medical School

    Budapest, 1083

  • Somogy County Kaposi Mór Teaching Hospital

    Kaposvár, 7400

  • Jósa András Teaching Hospital

    Nyíregyháza, 4400

  • University of Pécs 1st Department of Internal Medicine

    Pécs, 7624

Other trials in Hungary

Sweden4 sites

  • Linköping University Hospital

    Linköping, Östergötland County, 581 85

  • Skåne University Hospital, Department of Hematology

    Lund, 222 82

  • Karolinska University Hospital

    Stockholm, Huddinge, 141 57

  • Uppsala University Hospital

    Uppsala, 751 81

Other trials in Sweden

Australia3 sites

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Monash Health, Monash Medical Centre

    Melbourne, Victoria, 3168

  • Icon Cancer Care Icon South Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Austria3 sites

  • Hospital of the Elisabethinen Linz GmbH

    Linz, 4020

  • Salzburg University Hospital

    Salzburg, 5020

  • Hanusch Hospital

    Vienna, 1140

Other trials in Austria

Germany3 sites

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

  • Universitätsklinikum Frankfurt am Main

    Frankfurt, 60590

Other trials in Germany

Ireland3 sites

  • Cork University Hospital

    Cork

  • Adelaide and Meath Hospital, Incorporating the National Children's Hospital

    Dublin, Dublin 24

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Russia3 sites

  • State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",

    Kemerovo, 650066

  • State Budgetary Healthcare Institution of Moscow City

    Moscow, 129301

  • FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency"

    Saint Petersburg, 191024

Other trials in Russia

Estonia2 sites

  • North Estonia Medical Centre

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Switzerland2 sites

  • University Hospital and University of Bern; Inselspital Bern

    Bern, 3010

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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).

Being tested
rigosertib, Any approved or standard-of-care therapy, best supportive care (BSC)
Keywords
Myelodysplastic Syndrome, MDS
Medical subject headings
Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • rigosertibDrug

    Also called ON 01910.Na

    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).

  • Any approved or standard-of-care therapyDrug

    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.

  • best supportive care (BSC)Drug

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

  • best supportive care (BSC)Drug

    Patients will receive best supportive care (BSC).

Study groups in NCT02562443
Study groupRoleWhat they receive
rigosertib + best supportive care (BSC)ExperimentalNot described
Receives: Drug: rigosertib; Drug: best supportive care (BSC)
Physician's Choice (PC) + best supportive care (BSC)Active comparatorNot described
Receives: Drug: Any approved or standard-of-care therapy; Drug: best supportive care (BSC)

What is being measured

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

  1. 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.

    Measured: Up to 30 Months

Secondary outcomes (6)

  1. 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.

    Measured: Up to 30 Months

  2. 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.

    Measured: Up to 30 Months

  3. 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.

    Measured: Up to 30 Months

  4. 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.

    Measured: At Baseline, at Week 4, Every 4 Weeks thereafter, and at the End-of-treatment.

  5. 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.

    Measured: Up to 30 Months

  6. 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.

    Measured: Up to 30 Months

Timeline

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

  1. First posted29 Sep 2015 (estimated)
  2. Study start2 Dec 2015
  3. Primary completion26 Jul 2020
  4. Study completion26 Jul 2021

Why it stopped: Top line analysis indicated that the study had failed to achieve its primary endpoint.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02562443
Sponsor's protocol ID
Onconova 04-30
Other IDs
2015-001476-22, 2015
Acronym
INSPIRE
Status last verified
Sep 2022
First submitted
25 Sep 2015
Last updated
26 Sep 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26968357

  • 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.

    PubMed 27104980

  • 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.

    PubMed 27400247

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rigosertib and Any approved or standard-of-care therapy in people with Myelodysplastic Syndrome and MDS, run by Traws Pharma, Inc. at 158 sites in 22 countries.

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

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Japan, France, Italy, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

The study was stopped early (reason given: Top line analysis indicated that the study had failed to achieve its primary endpoint.). Results are not available in the source record.

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

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

What does the primary outcome measure?

Overall survival of all randomized patients and overall survival of patients scored as IPSS-R very high risk. (time frame: Up to 30 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02562443, which also lists 4 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.

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