Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER · Company Internal
interventional
26
1 country
10
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)Study Completion
August 2009
Actual (reported)The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 27, 2006
Actual (reported)August 2, 2006
Actual (reported)March 2009
Actual (reported)August 2009
Actual (reported)Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
Phase 1: Baseline up to 3 month of treatment
Phase 2: Efficacy measure
Phase 2: every 6 weeks after start of treatment
Phase 1: PK of Sagopilone + Cisplatin
Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
Phase 2: Duration of CR or PR
every 6 weeks after start of treatment
Phase 2: TTP
every 6 weeks after start of treatment
Phase 2: PFS
every 6 weeks after start of treatment
Phase 2: OS
every 3 months after start of treatment
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
Gerlingen, Baden-Wurttemberg, 70839, Germany
Löwenstein, Baden-Wurttemberg, 74245, Germany
München, Bavaria, 80336, Germany
München, Bavaria, 81675, Germany
Hamburg, Free and Hanseatic City of Hamburg, 21075, Germany
Frankfurt am Main, Hesse, 65929, Germany
Wiesbaden, Hesse, 65199, Germany
Bayer Study Director
Bayer
26 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2006
First Posted
August 2, 2006
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Essen, North Rhine-Westphalia, 45147, Germany
Mainz, Rhineland-Palatinate, 55131, Germany
Berlin, State of Berlin, 12200, Germany
Primary Completion
March 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
November 4, 2014
Record last verified: 2014-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: