A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of OratecanTM in Patients With Advanced Solid Cancer((Q1DX5/W)X2 for 3W)
Besides the main objective, there are 3 other objectives as follows.
1. To determine dose-limiting toxicity (DLT) of OratecanTM
2. To characterize the pharmacokinetics of HM30181A, irinotecan and its metabolites (SN-38
and SN-38G) following oral administration of OratecanTM
3. To evaluate anticancer activity of OratecanTM in patients with advanced solid
malignancies Groups of 3 patients per cohort or dose level will be treated with
escalating doses of irinotecan in combination with a fixed 60mg dose of HM30181A.
If 0/3 patients at any dose level experience a DLT, the dose of irinotecan will be escalated
by 10 mg/m2 in the next dose level. If 1/3 patients at any dose level experience a DLT, the
cohort will be expanded by 3 additional patients to 6 patients. If no additional patients
develop DLT, the dose of irinotecan will again be escalated in the next cohort of 3
patients. If 2/3 or 2/6 patients develop DLT, then dose escalation will cease, and the
previous dose will be declared the MTD.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity evaluation (safety evaluation): Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).
Toxicity will be evaluated on Day 21 during Cycle 1
Tae-Yoo Kim, M.D. Ph.D
Seoul National University Hospital
Korea: Food and Drug Administration