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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463982
• Other study ID #: HM-OTE-103
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2011
• Last updated: April 8, 2015
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hanmi Pharmaceuticals, Co., Ltd	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	No