A Phase Ib/II Trial of Belotecan and Ifosfamide in Patien... | NCT01784107

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

NCT01784107

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Feb 10, 2016Estimated

Enrollment

45Estimated

Phase

Phase 1Phase 2

Conditions

Small Cell Lung Cancer

Interventions

Belotecan and Ifosfamide

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2018Estimated

Completion Date

Not provided

First Submitted Date

Jan 30, 2013

First Submission Date that Met QC Criteria

Feb 3, 2013

First Posted Date

Feb 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2016

Last Update Posted Date

Feb 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Kyung Cho, Professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Label	Type	Description	Intervention Names
Belotecan and Ifosfamide	Experimental		Drug: Belotecan and Ifosfamide

Name	Type	Description	Arm Group Labels	Other Names
Belotecan and Ifosfamide	Drug		Belotecan and Ifosfamide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MTD (maximal tolerated dose)		one year

Secondary Outcomes

Measure	Description	Time Frame
DLT(dose-limiting toxicity)		one year

Other Outcomes

Measure	Description	Time Frame
Response rate		one year
PFS(Progression-Free-Survival)		one year
Overall Survival

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee Kyung Ahn	Contact	+82-32-460-3229		hkahn@gilhospital.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center	Recruiting	Incheon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C116963	belotecan
D007069	Ifosfamide

Ancestor Terms

ID	Term
D003520	Cyclophosphamide
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds

Browse Leaves

Not provided

Browse Branches

Not provided