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Completed

NCT Number: NCT01463982

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

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

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Key information

Conditions

Solid Tumor Advanced Cancer

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hanmi Pharmaceuticals, Co., Ltd

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Oratecan and Capecitabine

Drug

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 names: Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

Primary outcomes

  1. Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination

    Time frame: Cycle 1 (21 days)

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 2, 2011
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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