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A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359359
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 27, 2006
First Posted Date  ICMJE August 2, 2006
Last Update Posted Date November 4, 2014
Study Start Date  ICMJE July 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin [ Time Frame: Phase 1: Baseline up to 3 month of treatment ]
  • Phase 2: Efficacy measure [ Time Frame: Phase 2: every 6 weeks after start of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
  • Phase I part: Maximum tolerated dose and dose-limiting toxicity in combination with cisplatin, Safety and tolerability
  • Phase II part: Anti-tumor activity (objective response - CR or PR - according to modRECIST criteria) of ZK 219477 in combination with cisplatin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Phase 1: PK of Sagopilone + Cisplatin [ Time Frame: 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 [ Time Frame: every 6 weeks after start of treatment ]
    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.
  • Phase 2: TTP [ Time Frame: every 6 weeks after start of treatment ]
    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.
  • Phase 2: PFS [ Time Frame: every 6 weeks after start of treatment ]
    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
  • Phase 2: OS [ Time Frame: every 3 months after start of treatment ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
  • Phase I part: Pharmacokinetics of ZK 219477 and cisplatin when given as combination, Anti-tumor activity (objective response - CR or PR - according to modRECIST criteria) of ZK 219477 in combination with cisplatin
  • Phase II part: Safety and tolerability, Population pharmacokinetics of ZK 219477 and cisplatin
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
Official Title  ICMJE 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)
Brief Summary 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
Detailed Description The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Small Cell
Intervention  ICMJE
  • Drug: Sagopilone (BAY86-5302, ZK 219477)
    Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
  • Drug: Cisplatin
    75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
Study Arms  ICMJE Experimental: Sagopilone and cisplatin
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
Interventions:
  • Drug: Sagopilone (BAY86-5302, ZK 219477)
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2009)
26
Original Enrollment  ICMJE
 (submitted: August 1, 2006)
40
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359359
Other Study ID Numbers  ICMJE 91495
2006-000067-29 ( EudraCT Number )
310101 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP