Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)

NCT ID: NCT00080015

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-12

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Diflomotecan (BN80915)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Uncontrollable brain metastasis
* Treated with an investigational drug within 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Other Identifiers

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2004-001350-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2-91-52990-708

Identifier Type: -

Identifier Source: org_study_id

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