A Phase I Study of ZIO-201-T in Combination With Doxorubicin in Subjects With Advanced, Refractory Solid Tumors for Which no Standard Therapy Exists and for Whom Treatment With Doxorubicin is Considered Medically Acceptable

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