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

Carcinoma, Small Cell Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359359
• Other study ID #: 91495
• Secondary ID: 2006-000067-2931
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2006
• Last updated: November 3, 2014
• Start date: July 2006
• Est. completion date: August 2009

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Small Cell Lung Carcinoma

Intervention

Drug:
• Sagopilone (BAY86-5302, ZK 219477)
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
• Cisplatin
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin		Phase 1: Baseline up to 3 month of treatment	Yes
Primary	Phase 2: Efficacy measure		Phase 2: every 6 weeks after start of treatment	No
Secondary	Phase 1: PK of Sagopilone + Cisplatin		Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion	No
Secondary	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.	every 6 weeks after start of treatment	No
Secondary	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.	every 6 weeks after start of treatment	No
Secondary	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	every 6 weeks after start of treatment	No
Secondary	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	every 3 months after start of treatment	No

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