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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)

Phase 1
19 Years
Not Enrolling
Advanced Solid Malignancies

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Trial Information

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.

Inclusion Criteria:

- Histologically or cytologically confirmed advanced solid tumors

- Patients who have experienced progressive disease despite of conventional anticancer
therapy. Patients who cannot expect effective treatment or prolonged survival with
conventional anticancer therapy

- Previous chemotherapy (excluding irinotecan), radiotherapy and surgical operation are
allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse
events are resolved (6 weeks for nitrosoureas and mitomycin)

- Aged ≥18

- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to

- A life expectancy greater than 12 weeks

- Adequate bone marrow (platelet≥100 x 109/L, hemoglobin≥10.0g/dl and ANC≥ 1.5 x 109/L,
renal (Creatinine≤1.5mg/dl) and liver function (AST/ALT/ALP ≤ 3 x upper limit of
normal and total bilirubin≤2mg/dl) and no abnormal heart and lung function However,
AST/ALT/ALP ≤ 5 x upper limit of normal for patients with liver metastases and ALP
level ≤ 5 x upper limit of normal for patients with bone metastases are allowed.

- Patients with no need of radiotherapy (except for true oncologic emergency occurring
after entry on study [e.g. acute spinal cord compression], other anticancer drugs and
immunotherapy during the trial

- Subjects must provide written informed consent prior to performance of study specific
procedures or assessments, and must be willing to comply with treatment and follow up
assessments and procedures

Exclusion Criteria:

- Patients with hematopoietic malignancies ( including leukemia, lymphoma, multiple
myeloma, myelodysplastic syndromes, myeloproliferative disorders), ileus, CNS
metastasis, and with active infections requiring parenteral or systemic
antibacterial, antiviral, or antifungal therapy. Patients with infections may
participate in this clinical trial after complete recovery or control of the

- Patients with chronic malabsorption, or who have undergone total colectomy

- Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are
candidates for planned HSCT

- History of congestive heart failure, atrial arrhythmia or ventricular arrhythmia
requiring medication; Patients who had treatment for myocardial infarction or any
other acute coronary syndrome event within the past 6 months.

- Subjects who, in the investigator's opinion, cannot be treated per protocol due to
functional impairments due to any other severe co-morbid medical conditions

- Pregnant or breast-feeding patients; Women of childbearing potential without adequate
contraception (Men must use adequate contraception.)

- Subjects who have no intention of following the requirements of the protocol or the
follow-up management. Subjects who cannot be followed up regularly due to
psychological, social, family, logistic, and geographical reasons.

- Subjects who have been treated with PGP inhibitors (cyclosporine A and verapamil),
which are contraindicated medications, will have a wash-out period of 2 weeks.

- Subjects who were administered with other investigational products within 28 days
before screening.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

Toxicity will be evaluated on Day 21 during Cycle 1

Safety Issue:


Principal Investigator

Tae-Yoo Kim, M.D. Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

September 2012

Related Keywords:

  • Advanced Solid Malignancies
  • HM30181A
  • Irinotecan
  • MTD
  • DLT
  • Neoplasms