Clinical trial NCT00608803 (phase 1, status: completed)
Conditions: advanced cancer
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: zio-201-t and doxorubicin
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Histological or cytological documentation of cancer

          -  Measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

          -  Ifosfamide and doxorubicin naïve

          -  Life expectancy of at least 12 weeks

          -  Adequate bone marrow, liver, and renal function, as assessed by the following
             laboratory requirements conducted within 7 days prior to dosing:Hemoglobin >9.0 g/dL,
             Absolute neutrophil count (ANC) >1,500/mm3,Platelet count ≥100,000/mm3,Total bilirubin
             <1.5×ULN,ALT and AST ≤2.5×ULN,Partial thromboplastin [PT]-INR/activated partial
             thromboplastin time [PTT] <1.5×ULN. Subjects who are being therapeutically
             anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed
             provided there is no prior evidence of underlying abnormality in coagulation
             parameters. If an interaction between study drug and anticoagulant is suspected,
             anticoagulation monitoring should be increased as appropriate. Serum creatinine ≤ULN

          -  Written, informed consent must be obtained from a potential subject prior to the
             conduct of any study-specific procedures

          -  Male and female subjects must agree to use adequate birth control measures/barrier
             control during the course of the trial.

          -  Women of childbearing potential must have a pregnancy test performed within 7 days of
             the start of treatment.

        Exclusion Criteria:

          -  Clinically evident congestive heart failure >Class II of the New York Heart
             Association (NYHA) guidelines

          -  Serious, clinically significant cardiac arrhythmias, defined as the existence of an
             absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V

          -  History and/or signs of active coronary artery disease/ischemia with or without angina
             pectoris

          -  Serious myocardial dysfunction defined as scintigraphically (MUGA, myocardial
             scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or
             an LVEF below the normal limit (one or both criteria is sufficient for exclusion)

          -  History of HIV infection

          -  Prior nephrectomy of history of urinary tract obstruction

          -  Active, clinically serious infection requiring systemic antibacterial, antifungal, or
             antiviral therapy

          -  Any major surgery within 3 weeks prior to start of treatment

          -  Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive
             therapy and has a negative imaging study within 4 weeks of study entry. In addition,
             the subject must not be undergoing acute steroid therapy or taper (chronic steroid
             therapy is acceptable, provided the dose is stable for 1 month prior to study start,
             and following screening radiographic studies).

          -  History of seizure disorder (a subject with seizures related to brain metastasis will
             be allowed provided he/she has been seizure-free for at least 2 months and meets the
             criteria defined above for inclusion of subjects with brain metastasis)

          -  Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell
             carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies
             curatively treated >3 years prior to entry)

          -  Pregnancy or lactation

          -  Substance abuse or medical, psychological, or social conditions that may interfere
             with the subject's participation in the study or evaluation of the study results

          -  Any condition that is unstable or could jeopardize the safety of a subject and his/her
             compliance with the protocol requirements