Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)
The main objective of this study is to determine the maximum tolerated dose (MTD) of OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy.
The irinotecan hydrochloric acid (HCl) tablet is escalated and administered per body surface area (BSA). The dose of HM30181A 60 mg is fixed.
The Route of administration of irinitecan and HM30181A is oral. Each cycle consists of 21 days. Drugs are administered daily for 10 consecutive days (D1, 2, 3, 4, 5, 8, 9, 10, 11 and 12) followed by a washout of 9 days.
|Advanced Solid Malignancies||Drug: HM30181AK tablet + Irinotecan tablets||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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)|
- 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). [ Time Frame: Toxicity will be evaluated on Day 21 during Cycle 1 ]
|Study Start Date:||June 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: HM30181AK tablet + Irinotecan tablets
HM30181AK tablet + Irinotecan tablets
Drug: HM30181AK tablet + Irinotecan tablets
HM30181AK 60 mg tablet + Irinotecan 20mg, 5 mg or 2mg tablets
Besides the main objective, there are 3 other objectives as follows.
- To determine dose-limiting toxicity (DLT) of OratecanTM
- To characterize the pharmacokinetics of HM30181A, irinotecan and its metabolites (SN-38 and SN-38G) following oral administration of OratecanTM
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986843
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Tae-Yoo Kim, M.D. Ph.D||Seoul National University Hospital|