Trial Search Results
Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing 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.
Stanford is currently not accepting patients for this trial.
Onconova Therapeutics, Inc.
- Drug: rigosertib sodium
- 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.
- 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
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study