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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ziopharm.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT00592163
First received: December 26, 2007
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592163

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

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00592163     History of Changes
Other Study ID Numbers: SGC1002
Study First Received: December 26, 2007
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Ziopharm:
Cancer
Arsenic

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014