Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies (Oratecan-103)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hanmi Pharmaceutical Company Limited.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited Identifier:
First received: October 31, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine

Condition Intervention Phase
Advanced Solid Malignancies
Drug: Irinotecan, HM30181AK, Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer

Resource links provided by NLM:

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Irinotecan, HM30181AK, Capecitabine
    Oratecan in combination with Capecitabine
Detailed Description:

Besides the main objective, there are 4 other objectives as follows:

  • To assess the safety of Oratecan in combination with capecitabine
  • To evaluate anticancer activity of Oratecan in combination with capecitabine in patients with advanced solid malignancies
  • To characterize the pharmacokinetics of Oratecan and its metabolites following oral administration of OratecanTM in combination with capecitabine

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced solid tumor
  • 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, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
  • Aged ≥19
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
  • A life expectancy greater than 12 weeks
  • Adequate bone marrow, renal and liver function.
  • 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,uncontrolled infection, CNS metastasis.
  • Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
  • Patients who have GI malabsorption or difficulty taking oral medication
  • Patients who have psychiatric or congenital disorder Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
  • Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01463982

Contact: Kyung Mi Park

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tae Yoo Kim, MD, PhD         
Principal Investigator: Tae Yoo Kim, MD, PhD         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01463982     History of Changes
Other Study ID Numbers: HM-OTE-103
Study First Received: October 31, 2011
Last Updated: October 31, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on April 16, 2015