Status:
COMPLETED
Study of Oral Darinaparsin in Patients With Advanced Solid Tumors
Lead Sponsor:
Alaunos Therapeutics
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01139346
Start Date
June 1 2010
End Date
April 1 2012
Last Update
July 19 2012
Active Locations (3)
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1
Lafayette, Indiana, United States, 47905
2
Dallas, Texas, United States
3
Houston, Texas, United States