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



Status:Active, not recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Anemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:August 2013
End Date:February 2019

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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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
15
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Westwood, KS
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Adelaide, South Australia
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Adelaide,
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Chicago, Illinois 60637
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Houston, Texas 77030
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Rochester, Minnesota 55905
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Stanford, California 94305
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Stanford, CA
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