Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Peter L Greenberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

HEMMDS0023

NCT ID:

NCT00987584

Start Date:

June 2009

Completion Date:

February 2011

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Preleukemia
  • Trisomy

Name

Location

Stanford University School of MedicineStanford, California  94305-5317