NCT01784107

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

7 years

First QC Date

January 30, 2013

Last Update Submit

February 9, 2016

Conditions

Small Cell Lung Cancer

Keywords

SCLCbelotecanIfosfamide

Outcome Measures

Primary Outcomes (1)

  • MTD (maximal tolerated dose)

    one year

Secondary Outcomes (1)

  • DLT(dose-limiting toxicity)

    one year

Other Outcomes (4)

  • Response rate

    one year

  • PFS(Progression-Free-Survival)

    one year

  • Overall Survival

    one year

  • +1 more other outcomes

Study Arms (1)

Belotecan and Ifosfamide

EXPERIMENTAL
Drug: Belotecan and Ifosfamide

Interventions

Belotecan and IfosfamideDRUG
Belotecan and Ifosfamide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • acute or active infection
  • uncontrolled cerebral nerve symptoms or metastasis
  • significant myocardial infarction or cardiac disease within 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

belotecanIfosfamide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Hee Kyung Ahn

CONTACT

+82-32-460-3229hkahn@gilhospital.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 5, 2013

Study Start

July 1, 2011

Primary Completion

July 1, 2018

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

KR(1)