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Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy 8/Intermed-1, 2/High Risk

Sponsor
Peter L Greenberg (Other)
Overall Status
Completed
CT.gov ID
NCT00987584
Collaborator
The Leukemia and Lymphoma Society (Other)
13
Enrollment
1
Location
20
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.

This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Biologic Correlates Study for "A Phase 2 Single-Arm Study To Assess The Efficacy and Safety Of 48-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Once a Week for 3 Weeks of a 4-Week Cycle in Myelodysplastic Syndrome Patients With Trisomy 8 or Classified as Intermediate-2 or High Ris
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2011
    Actual Study Completion Date :
    Feb 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Hematologic responses [4 months]

      Marrow blast decrement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of IPSS Intermediate or High risk MDS by bone marrow biopsy, marrow cytogenetics and blood counts, using FAB morphologic criteria

    • Eastern Cooperative Oncology (ECOG) performance status of 0-2

    • Adequate Liver Function, as evidenced by a serum bilirubin less or equal to 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilberts Disease) or an ALT and AST 3 times the laboratory normal range

    • A serum creatinine concentration less or equal to 2mg/dl

    • Subjects must be equal or greater than 18 years of age at the time of obtaining informed consent

    • Written informed consent

    Exclusion Criteria:

    • Prior history of leukemia or aplastic anemia

    • Prior history of bone marrow transplantation

    • Platelet count <100,000/mm^3

    *Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization

    • Active or uncontrolled infections

    • Unstable angina, congestive heart failure [NYHA>classII], uncontrolled hypertension [diastolic >100mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction

    • Less than 4 weeks since receipt of any investigational product or device

    • Pregnant or breast feeding

    • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator

    • Previously enrolled in this study

    • Will not be available for follow-up assessments

    • Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Peter L Greenberg
    • The Leukemia and Lymphoma Society

    Investigators

    • Principal Investigator: Peter L Greenberg, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter L Greenberg, Professor Emeritus, Stanford University
    ClinicalTrials.gov Identifier:
    NCT00987584
    Other Study ID Numbers:
    • IRB-15469
    • HEMMDS0023
    First Posted:
    Oct 1, 2009
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome
    Trisomy

    Study Results

    No Results Posted as of Mar 25, 2020