Clinical Trial: BI 2536 Second Line Monotherapy in SCLC
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell
Brief Summary: Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome: Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI) [ Time Frame: at least 6 weeks ]
Original Primary Outcome: Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI)
Current Secondary Outcome:
- Progression-free survival [ Time Frame: at least 6 weeks ]
- Overall survival [ Time Frame: at least 6 weeks ]
- Duration of overall response [ Time Frame: at least 6 weeks ]
- Occurrence and intensity of adverse events graded according to CTCAE [ Time Frame: at least 6 weeks ]
- Occurrence of dose limiting toxicity [ Time Frame: at least 6 weeks ]
- Number of patients with significant abnormalities in laboratory parameters [ Time Frame: 36 weeks ]
Original Secondary Outcome:
- Progression-free survival
- Overall survival
- Duration of overall response
- Incidence and intensity of adverse events
- Safety, PK
Information By: Boehringer Ingelheim
Dates:
Date Received: December 18, 2006
Date Started: January 2007
Date Completion:
Last Updated: April 30, 2014
Last Verified: April 2014