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Study to Assess of Belotecan or Topotecan on Daily Schedule in Relapsed Small Cell Lung Cancer (SCLC) Patients

This study is currently recruiting participants.
Verified September 2015 by Chong Kun Dang Pharmaceutical
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497873
First Posted: December 23, 2011
Last Update Posted: September 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
  Purpose
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.

Condition Intervention Phase
Small Cell Lung Cancer Drug: Topotecan Drug: Belotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Objectives Response Rate(ORR, %) [ Time Frame: Up to 18weeks ]

Secondary Outcome Measures:
  • Overall Survival(OS) [ Time Frame: 7years ]
  • Progression Free survival(PFS) [ Time Frame: Up to 18weeks ]

Estimated Enrollment: 176
Study Start Date: September 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belotecan
Camtobell Injection
Drug: Belotecan
0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Other Name: Camtobell Injection
Active Comparator: Topotecan
Hycamtin Injection
Drug: Topotecan
1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
Other Name: Hycamtin Injection

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 first-line 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/μL
    • platelet count ≥ 100,000 cells/μL
    • hemoglobin ≥ 9 g/dL
    • Total bilirubin ≤ 1.5 X ULN
    • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497873


Contacts
Contact: Heungtai Kim, PhD, Dr 82-31-920-0408

Locations
Korea, Republic of
Chungbuk University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Ki Hyung Lee    82-43-269-6015      
Keimyung University Dongsan Center Recruiting
Daegu, Korea, Republic of
Contact: Hong Suk Song    82-53-250-7436      
National Cancer Center Recruiting
Goyang, Korea, Republic of, 410-769
Contact: Heung Tai Kim    82-31-920-1622      
Principal Investigator: Heung Tai Kim         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sang We Kim    82-2-3010-3215      
Chung-Ang University hospital Recruiting
Seoul, Korea, Republic of
Contact: Joung Soon Jang    82-2-6299-1427      
Kyung Hee University Medical Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae Heon Jeong    82-2-958-8723      
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jin Soo Kim    82-2-870-3202      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Wan Kim    82-2-2072-2995      
Seoul St. Marys Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Hyoung Kang    82-2-2258-2680      
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bong Seog Kim    82-2-2225-1319      
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hye Ryeon Kim    82-10-8713-4793      
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Jin Hyuk Choi    82-31-219-4920      
St. Vincents Hospital Recruiting
Suwon, Korea, Republic of
Contact: Hoon Kyo Kim    82-2-540-7935      
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Heung Tae Kim, M.D., Ph.D National Cancer Center
Principal Investigator: Jin Hyoung Kang, M.D., Ph.D Seoul St. Marys Hospital
Principal Investigator: Hong Suk Song, M.D., Ph.D Dongsan Medical Center
Principal Investigator: Dong Wan Kim, M.D., Ph.D Seoul National University Hospital
Principal Investigator: Sang We Kim, M.D., Ph.D Asan Medical Center
Principal Investigator: Hye Ryeon Kim, M.D., Ph.D Severance Hospital
Principal Investigator: Jin Hyuk Choi, M.D., Ph.D Ajou University School of Medicine
Principal Investigator: Ki Hyeong Lee, M.D., Ph.D Chungbuk National University Hospital
Principal Investigator: Hoon Kyo Kim, M.D., Ph.D St. Vincents Hospital
Principal Investigator: Jae Heon Jeong, M.D., Ph.D Kyung Hee University Medical Hospital
Principal Investigator: Jin Soo Kim, M.D., Ph.D SMG-SNU Boramae Medical Center
Principal Investigator: Joung Soon Jang, M.D., Ph.D Choung Ang University Hospital
Principal Investigator: Bong Seog Kim, M.D., Ph.D Seoul Veterans Hospital
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01497873     History of Changes
Other Study ID Numbers: 11SCLC09I
First Submitted: April 20, 2011
First Posted: December 23, 2011
Last Update Posted: September 16, 2015
Last Verified: September 2015

Keywords provided by Chong Kun Dang Pharmaceutical:
Small Cell Lung Cancer
Belotecan
Topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Belotecan
Camptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic