Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine

Completed · Phase 3

Conditions studied: Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Chronic Myelomonocytic Leukemia, Cytopenia

In brief

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.

Key facts

Study ID

NCT01928537

Run by

Traws Pharma, Inc.

People needed

67

Starts

2013-08-01

Expected to finish

2017-06-29

Last updated by the study team

2020-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Stanford University Cancer Center — Stanford, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• University of Kansas Cancer Center and Medical Pavilion — Westwood, Kansas, United States
• Greenbaum Cancer Center University of Maryland — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• New York Presbyterian Hospital-Weill Cornell Medical College — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Texas Southwestern Medical Center-Parkland Hospital — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Monash Health, Monash Medical Centre — Clayton, Victoria, Australia
• Peter MacCallum Cancer Center — East Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Rigshospitalet, Department of Hematology — Copenhagen, Capital Region, Denmark
• Aarhus University Hospital — Aarhus, Jylland, Denmark
• Hôpital Saint-Louis, Service d'Hématologie — Paris, IDF, France
• Institute Paoli Calmettes — Marseille, France
• Universitätsklinikum Frankfurt, Goethe Universität — Frankfurt am Main, Hesse, Germany
• Universitätsklinikum Köln Klinik I für Innere Medizin — Cologne, Germany
• University Hospital Carl Guslav Carus — Dresden, Germany

Full record on ClinicalTrials.gov

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