Trial Condition(s):
Carcinoma, Small Cell
A study of a new chemotherapy agent in combination with cisplatin to treat small cell lung cancer
Bayer Identifier:
91495
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Inclusion Criteria
- Small-cell lung cancer - Stage of extensive disease - Adequate function of major organs and systems - Use of highly effective birth control methods in females of child-bearing potential
Exclusion Criteria
- Prior chemotherapy for small-cell lung cancer - Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases - Superior vena cava syndrome or obstruction of any vital structure - Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation - Known allergy or hypersensitivity to platinum-containing drugs - Pregnancy or breast-feeding - Use of any investigational drug within 4 weeks before start of the study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Medizinische Einrichtungen der Universität Essen Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtische Kliniken Frankfurt am Main / Hoechst Frankfurt, Germany, 65929 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinik Harburg Hamburg, Germany, 21075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johannes-Gutenberg-Universität Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik Löwenstein gGmbH Löwenstein, Germany, 74245 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik Schillerhöhe Gerlingen, Germany, 70839 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HSK, Dr.-Horst-Schmidt-Kliniken Wiesbaden, Germany, 65199 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatinTimeframe: Phase 1: Baseline up to 3 month of treatment
- Phase 2: Efficacy measureTimeframe: Phase 2: every 6 weeks after start of treatment
Secondary Outcome
- Phase 1: PK of Sagopilone + CisplatinTimeframe: 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 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.Timeframe: every 6 weeks after start of treatment
- 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.Timeframe: every 6 weeks after start of treatment
- 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 assessmentTimeframe: every 6 weeks after start of treatment
- 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 aliveTimeframe: every 3 months after start of treatment
Additional Information
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