A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies
Male or female subjects with an age > 18 years Histologically or cytologically proven
malignancy, unresponsive to curative surgery, radiotherapy, conventional chemotherapy or
for which no conventional therapy exists. (Measurable or evaluable disease is desirable,
but not required) Note: This study is restricted to patients with advanced solid tumors,
subjects with hematological malignancies are excluded (including lymphoma and leukemia)
ECOG Performance Status 0- 2 Adequate bone marrow function, without the support of
cytokines and/or Epoetin Alpha within 5 days prior to dosing: Absolute neutrophil count
(ANC) >1,500/mm3, platelet count > 100,000/mm3, Hgb > 9.0 g/dL. Adequate liver function:
total bilirubin level < 2.0 mg/dL, ALT and AST < 2.0 x institutional upper limit of
normal in the absence of liver metastasis, or < 4.0 x institutional upper limit of normal
in the presence of liver metastasis.
Adequate renal function: serum creatinine < 1.5 mg/dL. At least 3 weeks since prior
chemotherapy or cancer surgery (6 weeks for nitrosourea or mitomycin C).
Normal cardiac function with no history of uncontrolled heart disease. Women subjects (if
of child bearing potential and sexually active) and male subjects (if sexually active with
a partner of child bearing potential) must use medically acceptable methods of birth
control prior to study entry and for the duration of the study. Medically acceptable
methods of contraception that may be used by the subject and/or his/her partner include
abstinence, birth control pills or patches, diaphragm and spermicide, IUD, condom and
vaginal spermicide, surgical sterilization, post menopausal, vasectomy, and progestin
implant or injection.
Written informed consent.
Subject is pregnant or is breast feeding. Subject's life expectancy is less than 3 months.
Subject exhibits confusion, disorientation, or has a history of major Psychiatric illness,
which may potentially impair subject's understanding of the informed consent.
Subject has signs and symptoms of acute infection requiring systemic therapy. Subject has
used another investigational agent within 30 days of dosing with S CKD602.
Subjects with known allergic reactions to camptothecin analogs, dextran sulfate or other
components of S-CKD602 Symptomatic or uncontrolled brain leptomeningeal metastasis. CT
scans are not required unless there is clinical suspicion of central nervous disease.
Not recovered from reversible toxicity of prior therapy. Subjects with known brain
metastases because of their poor prognosis because they often develop progressive
neurologic dysfunction that would confound the evaluation of neurologic and other adverse
Concurrent radiation therapy or radiation within 3 weeks of starting treatment with
Concurrent anti-neoplastic agents.