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Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986843
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : April 5, 2013
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Malignancies Drug: HM30181AK tablet + Irinotecan tablets Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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)
Study Start Date : June 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 2
  • 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 infection
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986843

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Principal Investigator: Tae-Yoo Kim, M.D. Ph.D Seoul National University Hospital

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Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT00986843     History of Changes
Other Study ID Numbers: HM-OTE-102
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
Keywords provided by Hanmi Pharmaceutical Company Limited:
Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents