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

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Advanced Cancer
• Intervention / Treatment: Drug: Oratecan 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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hanmi Pharmaceuticals, Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination	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)	Cycle 1 (21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)	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.	tumor response evaluation can continue to receive the study drug until PD confirmation

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Study Director: Jina Jung, PhD, Hanmi Pharmaceuticals.Co.,Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Advanced solid cancer
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Irinotecan
• Other Study ID Numbers: HM-OTE-103