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A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Topotecan
Belotecan
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, Belotecan, Topotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chungbuk University Hospital
  • Keimyung University Dongsan Center
  • National Cancer Center
  • Asan Medical Center
  • CHA Bundang Medical Center
  • Chung-Ang University hospital
  • Kyung Hee University Medical Hospital
  • Seoul National University Boramae Medical Center
  • Seoul National University Hospital
  • Seoul St. Marys Hospital
  • Seoul Veterans Hospital
  • Yonsei Cancer Center
  • Ajou University Hospital
  • St. Vincents Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Belotecan

Topotecan

Arm Description

Camtobell Injection

Hycamtin Injection

Outcomes

Primary Outcome Measures

Objectives Response Rate(ORR, %)
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

Secondary Outcome Measures

Overall Survival(OS)
Defined as the time from the randomization to the time of death.
Progression Free survival(PFS)
Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death

Full Information

First Posted
April 20, 2011
Last Updated
December 25, 2018
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01497873
Brief Title
A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, Belotecan, Topotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belotecan
Arm Type
Experimental
Arm Description
Camtobell Injection
Arm Title
Topotecan
Arm Type
Active Comparator
Arm Description
Hycamtin Injection
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin Injection
Intervention Description
1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Intervention Type
Drug
Intervention Name(s)
Belotecan
Other Intervention Name(s)
Camtobell Injection
Intervention Description
0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Primary Outcome Measure Information:
Title
Objectives Response Rate(ORR, %)
Description
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
Time Frame
Up to 18weeks
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Description
Defined as the time from the randomization to the time of death.
Time Frame
7years
Title
Progression Free survival(PFS)
Description
Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death
Time Frame
Up to 18weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heung Tae Kim, M.D., Ph.D
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Hyoung Kang, M.D., Ph.D
Organizational Affiliation
The Catholic University of Korea Seoul St. Marys Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Young Kim, M.D., Ph.D
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-Wan Kim, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-We Kim, M.D., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hye Ryeon Kim, M.D., Ph.D
Organizational Affiliation
Yonsei Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Hyuk Choi, M.D., Ph.D
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki Hyeong Lee, M.D., Ph.D
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ho Jung An, M.D., Ph.D
Organizational Affiliation
St. Vincents Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi Hoon Maeng, M.D., Ph.D
Organizational Affiliation
Kyung Hee University Medical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin-Soo Kim, M.D., Ph.D
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joung Soon Jang, M.D., Ph.D
Organizational Affiliation
Choung Ang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bong Seog Kim, M.D., Ph.D
Organizational Affiliation
Seoul Veterans Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, .D., Ph.D
Organizational Affiliation
CHA Bundang Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Center
City
Daegu
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Marys Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei Cancer Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
St. Vincents Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33191408
Citation
Kang JH, Lee KH, Kim DW, Kim SW, Kim HR, Kim JH, Choi JH, An HJ, Kim JS, Jang JS, Kim BS, Kim HT. A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer. Br J Cancer. 2021 Feb;124(4):713-720. doi: 10.1038/s41416-020-01055-5. Epub 2020 Nov 16.
Results Reference
derived

Learn more about this trial

A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

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