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

NCT01463982 | Completed Phase 1 Results

• 1 other identifier: HM-OTE-103
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor; Advanced Cancer

Keywords

Advanced solid cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)

  tumor response evaluation can continue to receive the study drug until PD confirmation

Study Arms (1)

Oratecan and Capecitabine

EXPERIMENTAL

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

Interventions

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

Also known as: Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

Oratecan and Capecitabine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi Pharmaceuticals, Co., Ltd

Seoul, South Korea

Location

MeSH Terms

Interventions

Capecitabine; Irinotecan

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Results Point of Contact

• Title: Director of clinical research team
• Organization: HanmiPharma

jajung@hanmi.co.kr

8224109038

Study Officials

• Jina Jung, PhD

  Hanmi Pharmaceuticals.Co.,Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 2, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 23, 2015
• Results First Posted: April 23, 2015

Record last verified: 2015-04

Locations

KR (1)