Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-101)
|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 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:||July 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Drug: HM30181AK tablet + Irinotecan 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: NCT00979563
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Yoon-ku Kang, MD, Ph.D||Asan Medical Center|