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Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Ziopharm.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Ziopharm Identifier:
First received: December 26, 2007
Last updated: July 18, 2012
Last verified: July 2012
A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas

Condition Intervention Phase
Advanced Solid Tumors Lymphomas Drug: ZIO-101-C (Darinaparsin) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas

Resource links provided by NLM:

Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • toxicities [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: ZIO-101-C (Darinaparsin)
Dose Escalation study, 200 mg - 900 mg, cumulative daily dose split to be taken BID 7 times a week (>8 hours between doses) for 3 weeks followed by 1 week of rest
Other Name: ZIO-101-C


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
  2. Men and women of ≥18 years of age.
  3. ECOG performance score ≤2.
  4. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST NOT have been in a previously irradiated field or injected with biological agents. Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria.
  5. Life expectancy ≥12 weeks.
  6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Baseline:

    • Creatinine ≤1.5 × upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 cc/min
    • Total bilirubin ≤2 × ULN
    • Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3 × ULN
    • Granulocytes in peripheral blood ≥1 × 109/L, hemoglobin ≥10 g/dL, and platelets ≥50,000 /μL
  7. Adequate vascular access for repeated blood sampling.
  8. Men and women of childbearing potential must agree to use effective contraception from Screening through the duration of Study participation.
  9. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.

Exclusion Criteria:

  1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction within 6 months
  2. 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); or documented history of prolonged QTc.
  3. Pregnant and/or lactating women.
  4. Uncontrolled systemic infection (documented with microbiological studies).
  5. Metastatic brain or meningeal tumors.
  6. Subjects with seizure disorder requiring medication (such as anti-epileptics).
  7. History of confusion or dementia or neurological condition that could mask a potential adverse response to the Study Drug, which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimers, and other neurological disorders.
  8. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry).
  9. Radiotherapy during study or within 3 weeks of Study entry.
  10. Surgery within 4 weeks of start of Study Drug dosing.
  11. Investigational drug therapy outside of this trial during or within 4 weeks of Study entry.
  12. History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
  13. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of Study results.
  14. Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the Study.
  15. Arsenic allergy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00592163

Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
  More Information

Responsible Party: Ziopharm Identifier: NCT00592163     History of Changes
Other Study ID Numbers: SGC1002
Study First Received: December 26, 2007
Last Updated: July 18, 2012

Keywords provided by Ziopharm:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on August 16, 2017