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Study Summary
No. 2010-0209:.......Leukemia......Guillermo Garcia-Manero......Leukemia
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Study Summary Title
Study Summary
Number:		2010-0209
Study Title:A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na Administered as a 72-Hour Continuous Intravenous Infusion Every Other Week in Myelodysplastic Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine or Decitabine
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Physician New Patient Referral
Name:Guillermo Garcia-ManeroPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3428
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:Onconova Therapeutics, Inc.
Phase of Study:Phase IIIReturn
Visit:
Treatment
Agents:		ON 01910.NaHome Care:
Treatment Loc:Both at MDACC & and Other Sites
Estimated
Length of Stay
in Houston:
Description/
Intervention:		The goal of this clinical research study is to learn if ON 01910.Na (also known
as Rigosertib) can help to control MDS. The safety of this drug is also being
studied.
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Study Objectives / Outcomes
The objectives of this study are as follows:

Primary objective:
The primary objective of the study is to compare overall survival (OS) in patients receiving 1800 mg/24 hr of ON 01910.Na via 72-hour continuous intravenous infusion administered every other week + 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) having failed, being intolerant, or progressing after azacitidine or decitabine treatment.

Secondary objectives:
Secondary objectives are to compare the BSC + ON 01910.Na group to the BSC group with respect to:
  • Overall response (complete and partial remission) according to 2006 IWG criteria (including, among the responders, the distribution of time to response and the duration of response);
  • Complete bone marrow response according to 2006 IWG criteria;
  • Hematological improvements in absolute neutrophil count (ANC), platelet count, and erythroid responses according to 2006 IWG criteria;
  • Improvements of cytogenetics as evaluated by the change in aneuploidy in bone marrow according to 2006 IWG criteria;
  • Transition time to AML:
    • Defined for RAEB-1 and RAEB-2 MDS and chronic myelomonocytic leukemia (CMML) patients (with BM blasts from 10% to 20% for CMML) by an increase of at least 50% BM blasts and more than 20% BM blasts;
    • Defined for RAEB-t by an increase of at least 50% BM blasts;
  • Quality-of-life (QOL) scores (using the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30 version 3).
  • Incidence of infections (treated with intravenous [IV] antimicrobials) and bleeding episodes.
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Study Status Information
Study Activation / Registration Date:12/02/2010
IRB Review and Approval Date:12/02/2010
Study Type:Phase Iii
Recruitment Status:Open
Projected Accrual:270
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) >/= 18 years of age

2) Diagnosis of MDS confirmed within 6 weeks prior to study entry according to WHO criteria or FAB classification

3) 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 WBC < 13,000/muL; RAEB-t (20% to 30% BM blasts), meeting the following criteria: - WBC < 25 x 10^9/L at study entry; - Stable WBC at least 4 weeks prior to study entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukophoresis;

4) At least one cytopenia (ANC < 1800/mu L or platelet count < 100,000/mu L or hemoglobin (Hgb) <10 g/dL)

5) Progression (according to 2006 IWG criteria) at any time after initiation of azacitidine or decitabine treatment during the 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 either four 4-week or four 6-week cycles of decitabine administered during the 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 either four 4-week or four 6-week cycles of decitabine administered during the past 2 years; or Intolerance to azacitidine or decitabine defined by drug-related >/=Grade 3 liver or renal toxicity leading to treatment discontinuation during the past 2 years;

6) Has failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation

7) Off all other treatments for MDS for at least 4 weeks. Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated.

8) No medical need for induction chemotherapy;

9) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

10) Willing to adhere to the prohibitions and restrictions specified in this protocol

11) Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
Exclusion Criteria:1) Anemia due to factors other than MDS (including hemolysis or gastrointestinal [GI] bleeding) unless stabilized for 1 week after RBC tranfusion

2) Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

3) Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

4) Active infection not adequately responding to appropriate therapy

5) Total bilirubin >/=1.5 mg/dL not related to hemolysis or Gilbert's disease

6) Alanine transaminase (ALT)/aspartate transaminase (AST) >/=2.5 x upper limit of normal (ULN)

7) Serum creatinine >/=2.0 mg/dL

8) Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L)

9) Female patients who are pregnant or lactating

10) Patients who are 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 [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study

11) Female patients with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin (betaHCG) pregnancy test at screening.

12) Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start

13) Uncontrolled hypertension (defined as a systolic pressure >/=160 mmHg and/or a diastolic pressure >/=110 mmHg)

14) New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures

15) Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy

16) Prior treatment with low dose cytarabine during the past 2 years

17) Investigational therapy within 4 weeks of starting ON 01910.Na

18) Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
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Links
Registration Number: NCT01241500
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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