A Phase I Trial of ZIO-101 in Solid Tumors: Protocol # SGL1002

Inclusion Criteria

Inclusion Criteria

1. Subjects with histological confirmation solid malignancy refractory to conventional
standard therapies for their condition

2. 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

3. Pediatric subjects will be eligible at the discretion of the primary investigator.

4. ECOG performance status score ≤ 2

5. Women of child-bearing potential (i.e., women who are pre-menopausal or not
surgically sterile) must use acceptable contraceptive methods (abstinence,
intrauterine device [IUD], oral contraceptive or double barrier device), and must
have a negative blood or urine pregnancy test within 1 week before beginning
treatment. Sexually active men must also use acceptable contraceptive methods

6. Subjects must provide written informed consent prior to treatment

7. At least 4 weeks from prior completion of prior therapy to day 1 of study drug

8. Baseline toxicity assessment ≤ grade 1 except treatment induced alopecia (NCI Common
Toxicity Criteria version 3.0)

9. Evidence of adequate multi-organ functional status as reflected by the following
clinical laboratory values:

- Serum creatinine ≤ 2 times the upper normal limit OR a calculated creatinine
clearance ≥ 50 cc/min

- Total bilirubin ≤ 2 times the upper normal limit

- Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3 times
the upper limit of normal

10. Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter,
hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to
50,000 /microL

Exclusion Criteria

1. Uncontrolled systemic infection (documented with microbiological studies)

2. Active heart disease as defined by an acute myocardial infarction within the previous
6 months before starting therapy, stable or unstable angina, clinically significant
arrhythmia requiring medical management, OR New York Heart Association Classification
of Functional Activities. Class 3: Subject has marked limitation in activities due to
symptoms, even during less-than-ordinary activity and is comfortable only at rest OR
Class 4: Severe limitations. Subject experiences symptoms even while at rest

3. Concomitant therapy for solid cancer

4. Pregnant subjects and those who are breast-feeding

5. History of an 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

6. Documented personal or family history of prolonged QT syndrome

7. 12 lead electrocardiogram with a corrected QT interval > 460 milliseconds

8. History of confusion or dementia

9. History of seizure disorder