check_circleStudy Completed

Carcinoma, Small Cell

Bayer Identifier:

91495

ClinicalTrials.gov Identifier:

NCT00359359

EudraCT Number:

2006-000067-29

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

Both

Age

18 - N/A
  • - 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
  • - 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
26
Trial Dates
July 2006 - August 2009
Phase
Phase 1/2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medizinische Einrichtungen der Universität EssenEssen, 45147, Germany
Terminated
Klinikum rechts der IsarMünchen, 81675, Germany
Terminated
Städtische Kliniken Frankfurt am Main / HoechstFrankfurt, 65929, Germany
Terminated
Asklepios Klinik HarburgHamburg, 21075, Germany
Terminated
Klinikum der Johannes-Gutenberg-UniversitätMainz, 55131, Germany
Terminated
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 80336, Germany
Completed
Klinik Löwenstein gGmbHLöwenstein, 74245, Germany
Terminated
Klinik SchillerhöheGerlingen, 70839, Germany
Completed
HSK, Dr.-Horst-Schmidt-KlinikenWiesbaden, 65199, Germany

Primary Outcome

  • Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
    date_rangeTime Frame:
    Phase 1: Baseline up to 3 month of treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Phase 2: Efficacy measure
    date_rangeTime Frame:
    Phase 2: every 6 weeks after start of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Phase 1: PK of Sagopilone + Cisplatin
    date_rangeTime Frame:
    Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
    enhanced_encryption
    Safety Issue:
    No
  • Phase 2: Duration of CR or PR
    Duration 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 treatment
    enhanced_encryption
    Safety Issue:
    No
  • Phase 2: TTP
    Time 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 treatment
    enhanced_encryption
    Safety Issue:
    No
  • Phase 2: PFS
    Progression 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 assessment
    date_rangeTime Frame:
    every 6 weeks after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Phase 2: OS
    Overall 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 alive
    date_rangeTime Frame:
    every 3 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.