A Phase I Trial of ZIO-101 in Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT00591396
First received: December 26, 2007
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

A Phase I Trial of ZIO-101 (Darinaparsin) in Solid Tumors


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of ZIO-101 in Solid Tumors: Protocol # SGL1002

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 ]

Enrollment: 40
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: ZIO-101 (Darinaparsin)
Dose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
Other Name: ZIO-101

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Subjects with histological confirmation solid malignancy refractory to conventional standard therapies for their condition
  2. 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
  3. Pediatric subjects will be eligible at the discretion of the primary investigator.
  4. ECOG performance status score ≤ 2
  5. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods
  6. Subjects must provide written informed consent prior to treatment
  7. At least 4 weeks from prior completion of prior therapy to day 1 of study drug
  8. Baseline toxicity assessment ≤ grade 1 except treatment induced alopecia (NCI Common Toxicity Criteria version 3.0)
  9. Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values:

    • Serum creatinine ≤ 2 times the upper normal limit OR a calculated creatinine clearance ≥ 50 cc/min
    • Total bilirubin ≤ 2 times the upper normal limit
    • Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
  10. Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 /microL

Exclusion Criteria

  1. Uncontrolled systemic infection (documented with microbiological studies)
  2. Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Subject has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Subject experiences symptoms even while at rest
  3. Concomitant therapy for solid cancer
  4. Pregnant subjects and those who are breast-feeding
  5. History of an 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
  6. Documented personal or family history of prolonged QT syndrome
  7. 12 lead electrocardiogram with a corrected QT interval > 460 milliseconds
  8. History of confusion or dementia
  9. History of seizure disorder
  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: NCT00591396

Locations
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00591396     History of Changes
Other Study ID Numbers: SGL1002
Study First Received: December 26, 2007
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014