Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421213
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : July 19, 2012
Information provided by (Responsible Party):

January 10, 2007
January 11, 2007
July 19, 2012
December 2006
April 2012   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: 6 months ]
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Complete list of historical versions of study NCT00421213 on Archive Site
toxicities [ Time Frame: 6 months ]
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Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hematologic Neoplasms
  • Bone Marrow Neoplasms
  • Non-Hodgkin's Lymphoma
Drug: Darinaparsin
300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
Other Name: ZIO-101
Experimental: Single Arm
Intervention: Drug: Darinaparsin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Hodgkin's or non-Hodgkin's Lymphoma.
  2. ≥ 1 prior therapy and currently requiring therapy.
  3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
  4. ≥ 18 years of age.
  5. ECOG performance score ≤ 2 (see Appendix 2).
  6. Life-expectancy ≥ 2 months.
  7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
  8. No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
  9. The following clinical laboratory values < 2 weeks before Baseline:

    • Creatinine ≤ 2X upper limit of normal (ULN).
    • Total bilirubin ≤ 2X ULN.
    • Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.

Exclusion Criteria

  1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB).
  2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
  3. Uncontrolled infection.
  4. Prior seizures ≥ grade-3 in CTC v.3 criteria.
  5. Arsenic allergy.
  6. Significant neuropathology, defined as grade > 2 per CTCAE Version 3.0.
  7. Confusion or dementia.
  8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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July 2012

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