NCT00328588

Brief Summary

A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
3 countries

8 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 2, 2008

Status Verified

December 1, 2007

Enrollment Period

3 months

First QC Date

May 19, 2006

Last Update Submit

December 26, 2007

Conditions

Lung CancerCancer of LungCancer of the LungNon-Small Cell Lung CarcinomaCarcinoma, Non-Small Cell Lung

Keywords

Treatment EfficacyTreatment EffectivenessDisease ManagementTreatmentSafety

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate (CR+PR)

    In first 6 cycles

Study Arms (1)

1

EXPERIMENTAL

7 days continuous infusion

Drug: YM155

Interventions

YM155DRUG

IV

1

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed non-small cell lung cancer.
  • Prior chemotherapy regimen(s) for lung cancer

You may not qualify if:

  • History of other malignancy in the last 5 years
  • Major surgery within the past 21 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chomutov, 43012, Czechia

Location

Unknown Facility

Novi Jicin, 74101, Czechia

Location

Unknown Facility

Ostrava, 70852, Czechia

Location

Unknown Facility

Prague, 15006, Czechia

Location

Unknown Facility

Prague, 18081, Czechia

Location

Unknown Facility

Großhansdorf, 22927, Germany

Location

Unknown Facility

Amsterdam, 1081HV, Netherlands

Location

Unknown Facility

Amsterdam, 3075 EA, Netherlands

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

sepantronium

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Medical Director

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

December 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 2, 2008

Record last verified: 2007-12

Locations

DE(1)CZ(5)NL(2)