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

This study has been completed.
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Peter L Greenberg, Stanford University
ClinicalTrials.gov Identifier:
NCT00987584
First received: September 24, 2009
Last updated: February 2, 2012
Last verified: February 2012

September 24, 2009
February 2, 2012
June 2009
January 2011   (final data collection date for primary outcome measure)
Not Provided
To determine the in vivo effects of ON-01910.Na on signaling pathways relevant to the drug's mechanism of action (Pharmacodynamic (PD) measurements).
Complete list of historical versions of study NCT00987584 on ClinicalTrials.gov Archive Site
Not Provided
To determine whether there is an association between intracellular signaling within cell subpopulations and clinical response to ON-01910.Na (Patient stratification and development of resistance).
Not Provided
Not Provided
 
Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy 8/Intermed-1, 2/High Risk
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

marrow and peripheral blood

Non-Probability Sample

Diagnosis of IPSS Intermediate or High risk MDS

Myelodysplastic Syndromes
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00987584
HEMMDS0023, 15469
Yes
Peter L Greenberg, Stanford University
Peter L Greenberg
The Leukemia and Lymphoma Society
Principal Investigator: Peter L Greenberg Stanford University
Stanford University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP