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NCT01784107 Clinical Trial

A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:
A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01784107
Other study ID # 2011-GIRBA-2550
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received January 30, 2013
Last updated February 9, 2016
Start date July 2011

Study information
Verified date February 2016
Source Gachon University Gil Medical Center
Contact Hee Kyung Ahn
Phone +82-32-460-3229
Email hkahn@gilhospital.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.

Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- histologically or cytologically confirmed extensive disease of Small cell lung cancer

- no prior chemotherapy or radiotherapy for lung

- measurable lesion for RECIST

- over 18 years

- ECOG 0~2

- expected life span more than 3 months

Exclusion Criteria:

- acute or active infection

- uncontrolled cerebral nerve symptoms or metastasis

- significant myocardial infarction or cardiac disease within 12 months

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Belotecan and Ifosfamide

Locations
Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Response rate one year Yes
Other PFS(Progression-Free-Survival) one year Yes
Other Overall Survival one year Yes
Other Number of participants with adverse events one year Yes
Primary MTD (maximal tolerated dose) one year Yes
Secondary DLT(dose-limiting toxicity) one year Yes
See also
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Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
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