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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

NCT ID: NCT01497873

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2018-03-31

Brief Summary

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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

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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

Conditions

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Small Cell Lung Cancer

Keywords

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Small Cell Lung Cancer Belotecan Topotecan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belotecan

Camtobell Injection

Group Type EXPERIMENTAL

Belotecan

Intervention Type DRUG

0.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

Topotecan

Hycamtin Injection

Group Type ACTIVE_COMPARATOR

Topotecan

Intervention Type DRUG

1.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

Interventions

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Topotecan

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

Belotecan

0.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

Intervention Type DRUG

Other Intervention Names

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Hycamtin Injection Camtobell Injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heung Tae Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Jin Hyoung Kang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea Seoul St. Marys Hospital

Jin Young Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Dong-Wan Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Sang-We Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Hye Ryeon Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Yonsei Cancer Center

Jin Hyuk Choi, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Ki Hyeong Lee, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Ho Jung An, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Vincents Hospital

Chi Hoon Maeng, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Medical Hospital

Jin-Soo Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Joung Soon Jang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Choung Ang University Hospital

Bong Seog Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul Veterans Hospital

Joo-Hang Kim, .D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

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Chungbuk University Hospital

Daegu, , South Korea

Site Status

Keimyung University Dongsan Center

Daegu, , South Korea

Site Status

National Cancer Center

Goyang, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

CHA Bundang Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University hospital

Seoul, , South Korea

Site Status

Kyung Hee University Medical Hospital

Seoul, , South Korea

Site Status

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Seoul St. Marys Hospital

Seoul, , South Korea

Site Status

Seoul Veterans Hospital

Seoul, , South Korea

Site Status

Yonsei Cancer Center

Seoul, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

St. Vincents Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33191408 (View on PubMed)

Other Identifiers

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11SCLC09I

Identifier Type: -

Identifier Source: org_study_id