Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts

Completed · Phase 3

Conditions studied: Myelodysplastic Syndromes, MDS, RAEB, Chronic Myelomonocytic Leukemia

In brief

The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.

Key facts

Study ID

NCT01241500

Run by

Traws Pharma, Inc.

People needed

299

Starts

2010-11-01

Expected to finish

2018-10-03

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…

• MDS diagnosis confirmed within 6 weeks prior to entry according to WHO or FAB classification
• MDS classified as follows, according to WHO and FAB classification:
• RAEB-1 (5% - 9% BM blasts)
• RAEB-2 (10% - 19% BM blasts)
• CMML (10% - 20% BM blasts) and WBC < 13,000/μL
• RAEB-t (20% - 30% BM blasts), with following criteria:
• o WBC < 25 x 10E9/L at entry
• o Stable WBC at least 4 weeks prior to entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukopheresis.
• At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin <10 g/dL)
• Progression according to 2006 International Working Group (IWG) criteria any time after start of azacitidine or decitabine during past 2 years; or failure to achieve complete or partial response or hematological improvement (according to 2006 IWG) after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or relapse after initial complete or partial response or hematological improvement (according to 2006 IWG criteria) observed after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine during past 2 years; or, intolerance to azacitidine or decitabine defined by drug-related ≥Grade 3 liver or renal toxicity leading to discontinuation during the past 2 years.
• Did not respond to, relapsed after, not eligible for, or opted not to do bone marrow transplantation
• Off other MDS treatments for at least 4 weeks; Filgrastim (G-CSF) and erythropoietin allowed before and during the study as clinically indicated.
• No need for induction chemotherapy
• ECOG status 0, 1 or 2
• Willing to adhere to protocol prohibitions and restrictions
• Patient (or a legally authorized representative) must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate

You may not qualify if…

• Anemia due to factors other than MDS (including hemolysis or gastrointestinal 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, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• Active infection not adequately responding to appropriate therapy
• 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
• Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L)
• Pregnant or lactating females
• Patients unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device, double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study
• Females with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin pregnancy test at screening
• Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start
• Uncontrolled hypertension (defined as systolic pressure ≥160 mmHg and/or diastolic pressure ≥110 mmHg)
• New onset seizures (within 3 months prior to first dose of ON 01910.Na) or poorly controlled seizures
• Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy
• Prior treatment with low-dose cytarabine during past 2 years Investigational therapy within 4 weeks of starting ON 01910.Na
• Psychiatric illness or social situation that limits the patient's ability to tolerate and/or comply with study requirements

Where it is running

• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Integrated Community Oncology Network — Jacksonville, Florida, United States
• Innovative Medical Research of South Florida, Inc. — Miami, Florida, United States
• Mount Sinai Comprehensive Cancer Centers — Miami Beach, Florida, United States
• Woodlands Medical Specialists — Pensacola, Florida, United States
• Martin Memorial Cancer Center — Stuart, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• North Shore Medical Center — Evanston, Illinois, United States
• Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Edward H. Kaplan MD & Associates — Skokie, Illinois, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Providence Cancer Center — Southfield, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Virginia G. Piper Cancer Center — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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