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

• ClinicalTrials.gov Identifier: NCT00359359
• Recruitment Status: Completed
• First Posted: August 2, 2006
• Last Update Posted: November 4, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: July 27, 2006
• First Posted Date: August 2, 2006
• Last Update Posted Date: November 4, 2014
• Study Start Date: July 2006
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
• 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)
• 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Small Cell

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 4, 2009): 26
• Original Enrollment (submitted: August 1, 2006): 40
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility 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
• 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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00359359
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Bayer
• Study Sponsor: Bayer
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: November 2014