NCT00592163UnknownPhase 1
Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Alaunos Therapeutics
- Enrollment
- 20
- Primary Endpoint
- toxicities
Study Overview
Brief Summary
A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
- •Men and women of ≥18 years of age.
- •ECOG performance score ≤
- •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.
- •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
- •New York Heart Association (NYHA) functional class ≥3 myocardial infarction 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.
- •Subjects 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, Alzheimers, and other neurological disorders.
- •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).
- •Radiotherapy during study or within 3 weeks of Study entry.
- •Surgery within 4 weeks of start of Study Drug dosing.
- •Investigational drug therapy outside of this trial during or within 4 weeks of 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 subject's participation in the study or evaluation of Study results.
- •Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the Study.
- •Arsenic allergy.
Arms & Interventions
Single Arm
Experimental
Intervention: ZIO-101-C (Darinaparsin) (Drug)
Outcomes
Primary Outcomes
toxicities
Time Frame: 6 months
Secondary Outcomes
- pharmacokinetics(6 months)
Investigators
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