check_circleStudy Completed
Carcinoma, Small Cell
Bayer Identifier:
91495
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study of a new chemotherapy agent in combination with cisplatin to treat small cell lung cancer
Trial purpose
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
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
26Trial Dates
July 2006 - August 2009Phase
Phase 1/2Could I Receive a placebo
NoProducts
Sagopilone (BAY86-5302)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medizinische Einrichtungen der Universität Essen | Essen, 45147, Germany |
Terminated | Klinikum rechts der Isar | München, 81675, Germany |
Terminated | Städtische Kliniken Frankfurt am Main / Hoechst | Frankfurt, 65929, Germany |
Terminated | Asklepios Klinik Harburg | Hamburg, 21075, Germany |
Terminated | Klinikum der Johannes-Gutenberg-Universität | Mainz, 55131, Germany |
Terminated | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Completed | Klinikum Innenstadt der Ludwigs-Maximilians-Universität | München, 80336, Germany |
Completed | Klinik Löwenstein gGmbH | Löwenstein, 74245, Germany |
Terminated | Klinik Schillerhöhe | Gerlingen, 70839, Germany |
Completed | HSK, Dr.-Horst-Schmidt-Kliniken | Wiesbaden, 65199, Germany |
Primary Outcome
- Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatindate_rangeTime Frame:Phase 1: Baseline up to 3 month of treatmentenhanced_encryptionyesSafety Issue:
- Phase 2: Efficacy measuredate_rangeTime Frame:Phase 2: every 6 weeks after start of treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Phase 1: PK of Sagopilone + Cisplatindate_rangeTime Frame:Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusionenhanced_encryptionNoSafety Issue:
- Phase 2: Duration of CR or PRDuration of complete response (CR) or partial response (PR) as ‘overall response’, defined as time between first date that the measurement criteria for CR or PR as ‘overall response’ are met and first date that recurrence or overall response of (progressive disease) PD is documented.date_rangeTime Frame:every 6 weeks after start of treatmentenhanced_encryptionNoSafety Issue:
- Phase 2: TTPTime to tumor progression (TTP) is defined as the time from the date of treatment assignment to the first observation of disease progression or to the last date of a definite assessment (not status unknown), if the patient is progression-free until that assessment.date_rangeTime Frame:every 6 weeks after start of treatmentenhanced_encryptionNoSafety Issue:
- Phase 2: PFSProgression free survival (PFS) is defined as the time from date of treatment assignment to the first observation of disease progression or death of any cause or to the last date of a definite assessment (not status unknown), if the patient was progression-free until that assessmentdate_rangeTime Frame:every 6 weeks after start of treatmentenhanced_encryptionNoSafety Issue:
- Phase 2: OSOverall survival (OS) is defined as the time from date of treatment assignment until death from any cause or until the last date the patient is known to be alivedate_rangeTime Frame:every 3 months after start of treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1