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

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ClinicalTrials.gov Identifier: NCT00592163
Recruitment Status : Unknown
Verified July 2012 by Ziopharm.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2008
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ziopharm

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE January 11, 2008
Last Update Posted Date July 19, 2012
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
toxicities [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00592163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
pharmacokinetics [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
Official Title  ICMJE Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
Brief Summary A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Lymphomas
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Single Arm
Intervention: Drug: ZIO-101-C (Darinaparsin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 26, 2007)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00592163
Other Study ID Numbers  ICMJE SGC1002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ziopharm
Study Sponsor  ICMJE Ziopharm
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ziopharm
Verification Date July 2012

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