Myelodysplastic SyndromesPhase 3NCT01928537
Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine
A Phase 3 study testing rigosertib sodium in people with Myelodysplastic Syndromes and Refractory Anemia With Excess Blasts, run by Traws Pharma, Inc. at 35 sites in 8 countries.
Trial summary
This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Chronic Myelomonocytic Leukemia
- What is being tested?
- rigosertib sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 35 sitesin 8 countries
- Study dates
- Aug 2013to 29 Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MDS confirmed within 6 weeks prior to Screening according to WHO criteria or French-American-British (FAB) classification.
- MDS classified as follows, according to WHO criteria and FAB classification:
- RAEB-1 (5% to 9% BM blasts)
- RAEB-2 (10% to 19% BM blasts)
- CMML (10% to 20% BM blasts) and white blood cells (WBC) < 13,000/μL
- RAEB-t (20% to 30% BM blasts), meeting the following criteria: WBC < 25,000/μL at study entry; or, Stable White Blood Cell (WBC) at least 4 weeks prior to Screening and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukopheresis.
Show all 19Show fewer
- At least one cytopenia (Absolute Neutrophil Count (ANC) < 1800/μL or Platelet (PLT) count < 100,000/μL or hemoglobin (Hgb) < 10 g/dL).
- Progression (according to 2006 IWG criteria) at any time after initiation of subcutaneous or intravenous azacitidine or decitabine treatment per labeling during the past 2 years, defined as follows:
- For patients with ˂ 5% BMBL, ≥ 50% increase in BMBL to ˃ 5% BMBL
- For patients with 5-10% BMBL, ≥ 50% increase in BMBL to ˃ 10% BMBL
- For patients with 10-20% BMBL, ≥ 50% increase in BMBL to ˃ 20% BMBL
- For patients with 20-30% BMBL, ≥ 50% increase in BMBL to ˃ 30% BMBL
- Any of the following: ≥ 50% decrease from maximum remission/response levels in granulocytes or PLT; Decrease in Hgb concentration by ≥ 2 g/dL; or, Transfusion dependence, defined as administration of at least 4 RBC units in the past 8 weeks before Screening (patients must have Hgb values ˂ 9 g/dL prior to transfusion to be considered), in the absence of another explanation.
- Has failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation.
- Off all other treatments for MDS for at least 4 weeks, except for azacitidine or decitabine. Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated.
- No medical need for induction chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Patient must signed an informed consent form.
Who cannot join
- Previous participation in a clinical study of IV or oral rigosertib.
- Anemia due to factors other than MDS (including hemolysis or gastrointestinal [GI] bleeding) unless stabilized for 1 week after RBC transfusion.
- Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.
- Uncontrolled intercurrent illness including.
- Active infection not adequately responding to appropriate therapy.
- Total bilirubin ≥ 1.5 mg/dL not related to hemolysis or Gilbert's disease.
Show all 19Show fewer
- ALT/AST ≥ 2.5 x upper limit of normal (ULN).
- Serum creatinine ≥ 2.0 mg/dL.
- Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L).
- Female patients who are pregnant or lactating.
- Patients who are unwilling to follow strict contraception requirements.
- Female patients with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin (βHCG) pregnancy test at Screening.
- Major surgery without full recovery or major surgery within 3 weeks of Baseline/Cycle 1 Day 1 visit.
- Uncontrolled hypertension (defined as a systolic pressure ≥160 mmHg and/or a diastolic pressure ≥ 110 mmHg).
- New onset seizures (within 3 months prior to Baseline) or poorly controlled seizures.
- Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy.
- Prior treatment with low-dose cytarabine during the past 2 years.
- Investigational therapy within 4 weeks of Baseline/Day 1 visit.
- Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
United States14 sites
Greenbaum Cancer Center University of Maryland
Baltimore, Maryland, 21201
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medicine
Chicago, Illinois, 60637
University of Texas Southwestern Medical Center-Parkland Hospital
Dallas, Texas, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
MD Anderson Cancer Center
Houston, Texas, 77030
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University Cancer Center
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10461
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205
Germany6 sites
Universitätsklinikum Köln Klinik I für Innere Medizin
Cologne, 50973
University Hospital Carl Guslav Carus
Dresden, 01062
Marien Hospital, Onkologie
Düsseldorf, 40479
Universitätsklinikum Frankfurt, Goethe Universität
Frankfurt am Main, Hesse, 60590
Universitätsmedizin Göttingen
Göttingen, 37075
Technische Universität München, III. Medizinische Klinik
München, 81675
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Peter MacCallum Cancer Center
East Melbourne, Victoria, 3002
Royal Melbourne Hospital
Parkville, Victoria, 3050
Italy3 sites
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
AOU Maggiore della Carità, SCUD Ematologia
Novara, 28100
Policlinico Umberto 1, Universita "Sapienza"
Rome, 00161
Sweden3 sites
Sahlgrenska University Hospital
Gothenberg, Västra Götalandsregionen, 41345
Skåne University Hospital,
Lund, Skåne County, SE-221 85
Karolinska University Hospital, Huddinge
Stockholm, SE-141 86
Denmark2 sites
Aarhus University Hospital
Aarhus, Jylland, DK-8000
Rigshospitalet, Department of Hematology
Copenhagen, Capital Region, DK-2100
France2 sites
Institute Paoli Calmettes
Marseille, 13009
Hôpital Saint-Louis, Service d'Hématologie
Paris, IDF, 75475
About this study
Official title: Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine
This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.
- Conditions
- Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Chronic Myelomonocytic Leukemia, Cytopenia
- Being tested
- rigosertib sodium
- Keywords
- International Working Group, azacitidine, decitabine
- Medical subject headings
- Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rigosertib sodiumDrug
Also called ON 01910.Na, SyB L-1101
| Study group | Role | What they receive |
|---|---|---|
| rigosertib sodium | Experimental | Rigosertib sodium will be administered as a 72-hr continuous intravenous infusion consisting of 3 consecutive doses of 1800 mg over 24 hours on Days 1, 2, and 3 of a 14-day cycle for the first 8 cycles and then on Days 1, 2, and 3 of a 28-day cycle for the following cycles. Receives: Drug: rigosertib sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship of bone marrow blast response and overall survival.
Bone marrow blast response is defined as bone marrow (BM) complete response, ≥ 50% BM blast decrease from pretreatment value, or stable BM response (no progression) according to the International Working Group (IWG) 2006 criteria and overall survival. Overall survival is defined as the time from first study treatment to death from any cause. All patients will be followed until death and/or progression, even if they have discontinued treatment for whatever cause. Survival time of patients lost to follow-up will be censored at the time they were last known to be alive.
Measured: Up to 2 years.
Secondary outcomes (9)
Number of patients with overall hematologic response.
Overall hematologic response (complete remission [CR], partial remission [PR], bone marrow complete response [BMCR], and stable disease [SD]) is defined according to 2006 International Working Group (IWG) response criteria.
Measured: Up to 2 years after study enrollment.
Number of patients with hematological improvement.
Hematological improvement (erythroid response, platelet response and neutrophil response) is defined according to 2006 International Working Group (IWG) response criteria.
Measured: Up to 2 years after study enrollment.
Number of patients with cytogenetic response.
Cytogenetic response is defined according to 2006 International Working Group (IWG) response criteria.
Measured: Up to 2 years after study enrollment.
Progression-free survival.
Progression-free survival is defined as time from date of first dose until date when progression is documented. Progression is defined according to 2006 International Working Group (IWG) response criteria.
Measured: Up to 2 years after study enrollment.
Number of patients who transition to Acute Myeloid Leukemia (AML)
Participants who progress to Acute Myeloid Leukemia (AML) during the study. AML is defined as an increase of at least 50% bone marrow blasts, and more than 20% bone marrow blasts for Refractory Anemia with Excess Blasts types 1 and 2 (RAEB-1 and RAEB-2) and Chronic Myelomonocytic Leukemia (CMML) patients and as an increase of at least 50% bone marrow blasts for Refractory Anemia with Excess Blasts in Transformation (RAEB-t) patients.
Measured: Up to 2 years after study enrollment.
Quality of Life Questionnaire
Change from baseline in responses in the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30 version 3. Questionnaire will be administered at baseline and at 4 week intervals.
Measured: Up to 2 years after study enrollment.
Infections.
Incidence of infections requiring treatment with intravenous antimicrobials and of bleeding episodes.
Measured: Up to 2 years after study enrollment.
Concentration of rigosertib in plasma.
Concentration of rigosertib in plasma will be measured by a validated High Performance Liquid Chromatography (HPLC) method.
Measured: Week 1 and week 3.
Safety.
Counts of patients who have adverse events (AEs). Adverse events will be grouped by system organ class (SOC) and preferred term (PT) using the most recent version of the Medical Dictionary for Regulatory Activities (MedDRA), and will be summarized by worst grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Measured: Study enrollment until 30 days after patient's last dose of rigosertib up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study startAug 2013
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Traws Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven M. Fruchtman, MD, Study chair, Traws Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928537
- Sponsor's protocol ID
- Onconova 04-24
- Other IDs
- 2013-001124-19
- Status last verified
- Jul 2018
- First submitted
- 21 Aug 2013
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olnes MJ, Shenoy A, Weinstein B, Pfannes L, Loeliger K, Tucker Z, Tian X, Kwak M, Wilhelm F, Yong AS, Maric I, Maniar M, Scheinberg P, Groopman J, Young NS, Sloand EM. Directed therapy for patients with myelodysplastic syndromes (MDS) by suppression of cyclin D1 with ON 01910.Na. Leuk Res. 2012 Aug;36(8):982-9. doi: 10.1016/j.leukres.2012.04.002. Epub 2012 Apr 21.
PubMed 22524974Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.
PubMed 21924492Silverman LR, Greenberg P, Raza A, Olnes MJ, Holland JF, Reddy P, Maniar M, Wilhelm F. Clinical activity and safety of the dual pathway inhibitor rigosertib for higher risk myelodysplastic syndromes following DNA methyltransferase inhibitor therapy. Hematol Oncol. 2015 Jun;33(2):57-66. doi: 10.1002/hon.2137. Epub 2014 Apr 29.
PubMed 24777753Al-Kali A. Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (HMA). Journal of Clinical Oncology 2017 35:15_suppl, 7056-7056 ASCO 2017
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine
- ClinicalTrials.gov ID
- NCT01928537
- Acronym / sponsor ID
- Onconova 04-24
- Conditions
- Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Chronic Myelomonocytic Leukemia, Cytopenia
- Keywords
- International Working Group, azacitidine, decitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 26 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rigosertib sodium | Experimental | Drug: rigosertib sodiumRigosertib sodium will be administered as a 72-hr continuous intravenous infusion consisting of 3 consecutive doses of 1800 mg over 24 hours on Days 1, 2, and 3 of a 14-day cycle for the first 8 cycles and then on Days 1, 2, and 3 of a 28-day cycle for the following cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of MDS confirmed within 6 weeks prior to Screening according to WHO criteria or French-American-British (FAB) classification.
- MDS classified as follows, according to WHO criteria and FAB classification:
- At least one cytopenia (Absolute Neutrophil Count (ANC) < 1800/μL or Platelet (PLT) count < 100,000/μL or hemoglobin (Hgb) < 10 g/dL).
- Progression (according to 2006 IWG criteria) at any time after initiation of subcutaneous or intravenous azacitidine or decitabine treatment per labeling during the past 2 years, defined as follows:
- Has failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation.
Key exclusion criteria (19 listed)
- Previous participation in a clinical study of IV or oral rigosertib.
- Anemia due to factors other than MDS (including hemolysis or gastrointestinal [GI] bleeding) unless stabilized for 1 week after RBC transfusion.
- Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.
- Uncontrolled intercurrent illness including.
- Active infection not adequately responding to appropriate therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rigosertib sodiumAlso: ON 01910.Na, SyB L-1101 | Drug | rigosertib sodium |
Primary outcome
Relationship of bone marrow blast response and overall survival.
Time frame: Up to 2 years.
Bone marrow blast response is defined as bone marrow (BM) complete response, ≥ 50% BM blast decrease from pretreatment value, or stable BM response (no progression) according to the International Working Group (IWG) 2006 criteria and overall survival. Overall survival is defined as the time from first study treatment to death from any cause. All patients will be followed until death and/or progression, even if they have discontinued treatment for whatever cause. Survival time of patients lost to follow-up will be censored at the time they were last known to be alive.
9 secondary outcomes
Number of patients with overall hematologic response.
Time frame: Up to 2 years after study enrollment.
Number of patients with hematological improvement.
Time frame: Up to 2 years after study enrollment.
Number of patients with cytogenetic response.
Time frame: Up to 2 years after study enrollment.
Progression-free survival.
Time frame: Up to 2 years after study enrollment.
Number of patients who transition to Acute Myeloid Leukemia (AML)
Time frame: Up to 2 years after study enrollment.
Quality of Life Questionnaire
Time frame: Up to 2 years after study enrollment.
Infections.
Time frame: Up to 2 years after study enrollment.
Concentration of rigosertib in plasma.
Time frame: Week 1 and week 3.
Safety.
Time frame: Study enrollment until 30 days after patient's last dose of rigosertib up to 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 22524974Olnes MJ, Shenoy A, Weinstein B, Pfannes L, Loeliger K, Tucker Z, Tian X, Kwak M, Wilhelm F, Yong AS, Maric I, Maniar M, Scheinberg P, Groopman J, Young NS, Sloand EM. Directed therapy for patients with myelodysplastic syndromes (MDS) by suppression of cyclin D1 with ON 01910.Na. Leuk Res. 2012 Aug;36(8):982-9. doi: 10.1016/j.leukres.2012.04.002. Epub 2012 Apr 21.
- Background: PubMed 21924492Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.
- Background: PubMed 24777753Silverman LR, Greenberg P, Raza A, Olnes MJ, Holland JF, Reddy P, Maniar M, Wilhelm F. Clinical activity and safety of the dual pathway inhibitor rigosertib for higher risk myelodysplastic syndromes following DNA methyltransferase inhibitor therapy. Hematol Oncol. 2015 Jun;33(2):57-66. doi: 10.1002/hon.2137. Epub 2014 Apr 29.
- Results publicationAl-Kali A. Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (HMA). Journal of Clinical Oncology 2017 35:15_suppl, 7056-7056 ASCO 2017
- Results publicationGarcia-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.
Related trials for Myelodysplastic Syndromes
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M. Fruchtman, MD study chair
Traws Pharma, Inc.
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rigosertib sodium in people with Myelodysplastic Syndromes and Refractory Anemia With Excess Blasts, run by Traws Pharma, Inc. at 35 sites in 8 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 19 inclusion and 19 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: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Germany, Australia, Italy, Sweden and 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship of bone marrow blast response and overall survival. (time frame: Up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928537, which also lists 5 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 30 Jun 2020.