Study of Oral Palifosfamide Tris in Solid Tumors
- Registration Number
- NCT00607711
- Lead Sponsor
- Alaunos Therapeutics
- Brief Summary
The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
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Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
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Men and women of ≥18 years of age.
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Life expectancy of at least 12 weeks.
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Eastern Cooperative Oncology Group (ECOG) performance score ≤2 (see Appendix 4).
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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.
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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 ≥70 cc/min
- Total bilirubin ≤2×ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN
- Granulocytes in peripheral blood ≥2.0×109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000/µL
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Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
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Men and women of childbearing potential must use effective contraception from Screening through his/her duration of study participation.
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Women of childbearing potential must have a negative serum pregnancy test prior to entering the study.
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New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months.
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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.
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Pregnancy and/or lactation.
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Uncontrolled systemic infection (documented with microbiological studies).
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Inadequate renal function as defined by the presence of one or more of the following:
- Creatinine clearance (CrCl) <70 cc/min
- Serum creatinine >1.5×ULN
- Prior nephrectomy
- Urinary tract obstruction
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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).
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Radiotherapy during study or within 3 weeks of study entry.
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Surgery within 4 weeks of start of study drug.
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Other investigational drug therapy outside of this trial during or within 4 weeks of study entry.
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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.
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Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of study results.
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Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm oral palifosfamide tris -
- Primary Outcome Measures
Name Time Method Toxicities 9 months
- Secondary Outcome Measures
Name Time Method Safety 9 months