A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors
1. Patient must understand and voluntarily sign an informed consent document.
2. Age 18 years at the time of signing Informed Consent
3. Histologically or cytologically documented solid tumors that are refractory to
standard/conventional therapy or for which no standard/conventional therapy exists.
4. Patients must have at least one measurable or non-measurable lesion according to the
RECIST Criteria (Appendix I).
5. Patient has an ECOG (Zubrod) performance status of ≤ 2.
6. Approximate life expectancy greater than 3 months.
7. Laboratory tests within these ranges:
- Absolute neutrophil count ≥ 1,500/μlL
- Platelet count ≥100,000/μL
- Serum creatinine ≤1.5 mg/dL
- Total bilirubin ≤1.5 mg/dL
- AST (SGOT)/ALT(SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic
8. The following prior treatments are allowable under this protocol:
9. Radiation, if discontinued at least 4 weeks prior to treatment under this protocol
Chemotherapy, if discontinued at least 4 weeks prior to treatment under this
protocol, and at least 6 weeks prior to treatment under this protocol for prior
nitrosurea or mitomycin-C treatment
10. Hormonal therapy for cancer, if discontinued at least 4 weeks prior to treatment
under this protocol
11. Other investigational drugs, if discontinued at least 4 weeks prior to treatment
under this protocol
12. Surgery, if minor surgery occurred at least 2 weeks prior to treatment under this
protocol, or at least 4 weeks since major surgery
13. Patient must be able to adhere to the study visit schedule and other protocol
14. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days prior to baseline. In addition, sexually active WCBP must agree to
use adequate contraceptive methods (oral, injectable, or implantable hormonal
contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
spermicide; or vasectomized partner).
1. Myocardial infarction within the previous 6 months, unstable angina,symptomatic
congestive heart failure, or other significant uncontrolled cardiac arrhythmia.
2. Cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein
thrombosis or other significant thromboembolic event in the previous 6 months.
3. Active infection, including known human immunodeficiency virus (HIV) positivity or
acquired-immunodeficiency-syndrome (AIDS)-related illness.
4. CNS metastases, unless controlled by previous radiation and the patient is
5. Any serious medical condition, laboratory abnormality or psychiatric illness that
would prevent the patient from signing the informed consent or limit survival to less
than 3 months.
6. Pregnant or nursing females.Female patients of childbearing potential who are
unwilling to use reliable contraceptive methods.
7. Any condition, including the presence of laboratory abnormalities, which in the
opinion of the Investigator places the patient at unacceptable risk if he/she were to
participate in the study.