Expired Study
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Stanford, California 94305


Purpose:

This is a phase 2 single arm study in which fourteen MDS patients with Trisomy 8 or classified as Intermediate-1, 2, or High risk who meet all other inclusion/exclusion criteria will receive ON 01910.Na 1800 mg/24h as an intravenous continuous infusion (IVCI) over 72 hours every other week for the first four 2-week cycles and every 4 weeks afterwards.


Study summary:

Primary Objective The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na CIV 1800 mg/24h for 72-hour infusion administered every other week for 8 weeks and every 4 weeks afterwards in achieving by week 29 a complete or partial response or hematological improvement as defined per the 2006 International Working Group (IWG) Criteria in Myelodysplastic Syndrome (MDS) patients with Trisomy 8 or classified as Intermediate-1, 2, or High risk. Secondary Objectives The secondary objectives are to assess: - Time and duration of bone marrow response - Complete or partial response according to International Working Group (IWG) 2006 criteria - Improvement of dyspoiesis as evaluated by the change in aneuploidy in bone marrow - Change in International Prognostic Scoring System (IPSS) - Responses in absolute neutrophil count, according to IWG 2006 criteria - Responses in platelet count, according to IWG 2006 criteria - Erythroid responses, according to IWG 2006 criteria - Time to progression - Overall survival at 29 and 53 weeks - Proportion of patients transitioning to acute myeloid leukemia (AML) at 29 and 53 weeks - Exploratory biomarkers on bone marrow aspirates (described in a separate companion protocol)


Criteria:

Inclusion Criteria:- > 18 years - Diagnosis of MDS via bone marrow aspirate and biopsy according to WHO Criteria and FAB Classification - Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months or Hemoglobin < 10 g/dL OR Thrombocytopenia (platelet count < 100,000/ul) OR Neutropenia (absolute neutrophil count < 1,500/ul) - Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation - Off all other treatments for MDS (including filgrastim (G-CSF) and erythropoietin) for at least four weeks. As an exception, filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented febrile neutropenia (<500/ul) - ECOG Performance Status 0, 1 or 2 - Adequate contraceptive [including 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 for female patients of reproductive potential - Female patient with reproductive potential must have a negative serum beta-HCG pregnancy test at screening - Willing to adhere to the prohibitions and restrictions specified in this protocol - Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study Exclusion Criteria:- Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding) - Proliferative (WBC >= 12,000/mm^3) chronic myelomonocytic leukemia - Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - History of HIV-1 seropositivity - 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, ALT or AST > 2 X ULN - Serum creatinine > 1.5 mg/dL or calculated creatinine clearance < 60 ml/min/1.73 m^2 - Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <134 Meq/L). - Women patients who are pregnant or lactating - Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol - Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start. - Uncontrolled hypertension (defined as a systolic pressure >= 160 and/or a diastolic pressure >= 110) - New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures - Any concurrent investigational agent or chemotherapy, radiotherapy or immunotherapy - Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements


NCT ID:

NCT01326377


Primary Contact:

Principal Investigator
Peter L Greenberg
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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