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

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ClinicalTrials.gov Identifier: NCT00080015
Recruitment Status : Completed
First Posted : March 23, 2004
Last Update Posted : July 24, 2009
Sponsor:
Information provided by:
Ipsen

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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Diflomotecan (BN80915) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.
Study Start Date : March 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Overall objective response rate (tumour assessments should be performed every 6 weeks)

Secondary Outcome Measures :
  1. Time to tumour progression
  2. Time to treatment failure
  3. Duration of overall response
  4. Overall complete response, partial response and stable disease
  5. Time to response
  6. Six month and one year survival rates
  7. Median survival
  8. Best overall response
  9. Overall objective response rate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main 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

Main Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080015


Sponsors and Collaborators
Ipsen
Investigators
Principal Investigator: Thierry Le Chevalier, MD Institut Gustave Roussy, Villejuif, Paris, France

ClinicalTrials.gov Identifier: NCT00080015     History of Changes
Other Study ID Numbers: 2-91-52990-708
First Posted: March 23, 2004    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action