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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00359359
First received: July 27, 2006
Last updated: May 5, 2013
Last verified: May 2013
  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


Condition Intervention Phase
Carcinoma, Small Cell
Drug: Sagopilone (BAY86-5302, ZK 219477)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with carboplatin and bevacizumab [ Time Frame: Phase 1: Baseline up to 3 month of treatment ] [ Designated as safety issue: Yes ]
  • Phase 2: Efficacy measure [ Time Frame: Phase 2: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase 1: PK of Sagopilone + Cisplatin [ Time Frame: Baseline up to 6 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Phase 2: Duration of CR or PR [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]
  • Phase 2: TTP [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]
  • Phase 2: PFS [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]
  • Phase 2: OS [ Time Frame: every 3 months after start of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sagopilone (BAY86-5302, ZK 219477)
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Known allergy or hypersensitivity to platinum-containing drugs
  • Pregnant or breast-feeding
  • Use of any investigational drug within 4 weeks before start of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359359

Locations
Germany
Gerlingen, Baden-Württemberg, Germany, 70839
Löwenstein, Baden-Württemberg, Germany, 74245
München, Bayern, Germany, 81675
München, Bayern, Germany, 80336
Frankfurt, Hessen, Germany, 65929
Wiesbaden, Hessen, Germany, 65199
Essen, Nordrhein-Westfalen, Germany, 45147
Mainz, Rheinland-Pfalz, Germany, 55131
Berlin, Germany, 12200
Hamburg, Germany, 21075
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00359359     History of Changes
Other Study ID Numbers: 91495, 2006-000067-29, 310101
Study First Received: July 27, 2006
Last Updated: May 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Small Cell
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014