Clinical Trials Logo
  1. Home
  2. Small Cell Lung Cancer
  3. NCT00080015
  4. Details
NCT00080015 Clinical Trial

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

Small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00080015
Other study ID # 2-91-52990-708
Secondary ID 2004-001350-92
Status Completed
Phase Phase 2
First received
Last updated
Start date March 12, 2004
Est. completion date February 2005

Study information
Verified date April 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Diflomotecan (BN80915)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Outcome
Type Measure Description Time frame Safety issue
Primary Overall objective response rate (tumour assessments should be performed every 6 weeks)
Secondary Time to tumour progression
Secondary Time to treatment failure
Secondary Duration of overall response
Secondary Overall complete response, partial response and stable disease
Secondary Time to response
Secondary Six month and one year survival rates
Secondary Median survival
Secondary Best overall response
Secondary Overall objective response rate
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03651219 - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03958045 - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma Phase 2
Completed NCT04381910 - Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04885998 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) Phase 1
Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
Not yet recruiting NCT02875457 - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin Phase 3
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Recruiting NCT02605811 - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer Phase 2
Completed NCT02551432 - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer Phase 2
Withdrawn NCT02542137 - Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT02262897 - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer Phase 2
Terminated NCT00969306 - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients Phase 1
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Terminated NCT00958022 - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer Phase 1
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3