A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer

Chong Kun Dang Pharmaceutical14 sites in 1 country164 target enrollmentSeptember 2010

ConditionsSmall Cell Lung Cancer

InterventionsBelotecan Topotecan

DrugsTopotecan Belotecan

Overview

Phase: Phase 2
Intervention: Belotecan
Conditions: Small Cell Lung Cancer
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 164
Locations: 14
Primary Endpoint: Objectives Response Rate(ORR, %)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.

Detailed Description

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

March 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age
•Histological or cytological diagnosis of SCLC
•Limited disease (LD) or Extensive disease (ED) at time of study entry
•Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
•Measurable disease defined by RECIST criteria
•ECOG Performance Status of 0, 1, or 2
•Life expectancy ≥ 3 months
•Adequate bone marrow, Renal, Hepatic reserve:
•absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance \> 60mL/min
•Signed a written informed consent

Exclusion Criteria

•Active infection
•Symptomatic brain lesion
•Any other type of cancer during the previous 5 years
•Severe concurrent diseases
•Prior anticancer therapy within 4 weeks before enroll
•Active pregnancy test and Pregnant or nursing women
•Participation in any investigational drug study within 28 days prior to study entry

Arms & Interventions

Belotecan

Camtobell Injection

Intervention: Belotecan

Topotecan

Hycamtin Injection

Intervention: Topotecan

Outcomes

Primary Outcomes

Objectives Response Rate(ORR, %)

Time Frame: Up to 18weeks

The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol