NCT00080015

Brief Summary

This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

March 12, 2004

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

March 19, 2004

Last Update Submit

April 27, 2020

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall objective response rate (tumour assessments should be performed every 6 weeks)

Secondary Outcomes (9)

  • Time to tumour progression

  • Time to treatment failure

  • Duration of overall response

  • Overall complete response, partial response and stable disease

  • Time to response

  • +4 more secondary outcomes

Interventions

Diflomotecan (BN80915)DRUG

Eligibility Criteria

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

You may qualify if:

  • Documented small cell lung cancer (SCLC)
  • Measurable disease
  • One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months

You may not qualify if:

  • Uncontrollable brain metastasis
  • Treated with an investigational drug within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

diflomotecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 19, 2004

First Posted

March 23, 2004

Study Start

March 12, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

April 29, 2020

Record last verified: 2020-04