Trial record 2 of 13 for:    Darinaparsin

Study of Oral Darinaparsin in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT01139346
First received: June 4, 2010
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

This study is a Phase I, dose escalation study of oral darinaparsin for the treatment of advanced solid tumors. Eligible patients could have received any amount of previous therapy.


Condition Intervention Phase
Advanced Solid Tumors
Drug: darinaparsin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Oral Darinaparsin in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Determine Toxicity Profile [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    a primary outcome measure is to determine the toxicity profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

  • Determine Maximum Tolerated Dose [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    a primary outcome measure is to determine the maximum tolerated dose of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

  • Determine the preliminary activity/efficacy [ Time Frame: One Year ] [ Designated as safety issue: No ]
    a primary outcome measure is to determine the preliminary activity/efficacy of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

  • Determine Pharmacokinetic profile [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    a primary outcome measure is to determine the pharmacokinetic profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle


Enrollment: 12
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral darinaparsin
open label, single arm, dose escalation
Drug: darinaparsin
dose escalating, starting at 200 mg twice per day for 21 days continuous followed by a 7 day rest per cycle.
Other Names:
  • ZIO-101-C
  • S-dimethylarsino-glutathione
  • Zinapar (TM)

  Eligibility

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

Inclusion Criteria:

  • Subjects with histological or cytological confirmation of advanced cancer (solid tumor) that is refractory to standard therapies for their condition;
  • Men and women of ≥18 years of age;
  • ECOG performance score ≤2
  • Eligible subjects with solid tumors MUST have at least one measurable lesion as defined by RECIST 1.1 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;
  • Life expectancy ≥12 weeks;
  • 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
  • Adequate vascular access for repeated blood sampling;
  • Men and women of childbearing potential must agree to use effective contraception from Screening through the duration of Study participation;
  • Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.

Exclusion Criteria:

  • Arsenic allergy.
  • New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 3) within 6 months.
  • 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.
  • Pregnant and/or lactating women.
  • Uncontrolled systemic infection (documented with microbiological studies).
  • Metastatic brain or meningeal tumors.
  • Patients with seizure disorder requiring medication (such as anti-epileptics)
  • 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, Alzheimer's, and other neurological disorders.
  • Anticancer chemotherapy or immunotherapy during the study or within four weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry)
  • Radiotherapy during study or within 3 weeks of Study entry.
  • Major surgery within 4 weeks of start of Study Drug dosing.
  • Other Investigational drug therapy during this trial within four weeks prior to Study entry.
  • 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.
  • Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of Study results.
  • Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.
  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: NCT01139346

Locations
United States, Indiana
Lafayette, Indiana, United States, 47905
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Sponsors and Collaborators
Ziopharm
Investigators
Study Director: Jonathan J. Lewis, MD, PhD ZIOPHARM, Oncology, Inc.
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01139346     History of Changes
Other Study ID Numbers: SGC1004
Study First Received: June 4, 2010
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ziopharm:
carcinoma
sarcoma
metastatic
solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014