Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01463982
First received: October 31, 2011
Last updated: April 8, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Solid Tumor
Advanced Cancer
Drug: Oratecan and Capecitabine
Phase 1

Study Type: Interventional
Study Design: 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:
  • Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination [ Time Frame: Cycle 1 (21 days) ] [ Designated as safety issue: Yes ]
    If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)


Secondary Outcome Measures:
  • Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) [ Time Frame: tumor response evaluation can continue to receive the study drug until PD confirmation ] [ Designated as safety issue: No ]

    by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.

    Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.

    Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100.



Enrollment: 21
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oratecan and Capecitabine

Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

  • Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
  • HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
  • Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14
Drug: Oratecan and Capecitabine

Oratecan in combination with Capecitabine

  • Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
  • HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
  • Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14
Other Name: Oratecan(HM30181AK + Irinotecan HCl) and 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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01463982

Locations
Korea, Republic of
Hanmi Pharmaceuticals, Co., Ltd
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Study Director: Jina Jung, PhD Hanmi Pharmaceuticals.Co.,Ltd
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01463982     History of Changes
Other Study ID Numbers: HM-OTE-103
Study First Received: October 31, 2011
Results First Received: April 8, 2015
Last Updated: April 8, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Advanced solid cancer

Additional relevant MeSH terms:
Capecitabine
Fluorouracil
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 29, 2015