Safety and Efficacy Study of a New Chemotherapy Agent to... | NCT00299390

Studies
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

NCT00299390

Sponsor

Bayer

Status

Terminated

Last Update Posted

Dec 31, 2015Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Small Cell Lung Carcinoma

Interventions

Sagopilone (BAY86-5302, ZK 219477)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Mar 3, 2006

First Submission Date that Met QC Criteria

Mar 3, 2006

First Posted Date

Mar 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2015

Last Update Posted Date

Dec 31, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Sagopilone	Experimental		Drug: Sagopilone (BAY86-5302, ZK 219477)

Name	Type	Description	Arm Group Labels	Other Names
Sagopilone (BAY86-5302, ZK 219477)	Drug	Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion	Sagopilone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to treatment according to the modRECIST (complete response or partial response)		Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Duration of complete or partial tumor response		Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Time to tumor progression		Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically proven Small-cell lung cancer (SCLC)
Stage of extensive disease defined by the presence of distant metastases
At least 1 unidimensionally measureable lesion
WHO performance status 0 to 1
No previous SCLC-related chemotherapy
No previous SCLC-related surgery
No previous radiotherapy (excepting for brain metastasis)
Adequate function of major organs and systems
- Nervous system
  - No Grade 2 or greater peripheral neuropathy
- Cardiovascular:
  - No symptomatic congestive heart failure
  - No unstable angina pectoris
  - No arrythmia needing continuous treatment
  - No other uncontrolled concurrent illness

Exclusion Criteria:

Superior vena cava syndrome or obstruction of any vital structure
Untreated malignant hypercalcemia
Pleural effusion as the only manifestation of disease
Extensive disease amenable to radiation therapy
Symptomatic brain metastases requiring whole brain irradiation
Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description	Link
2005-000597-53	EudraCT Number
307972

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

ID	Term
D055752	Small Cell Lung Carcinoma
D008175	Lung Neoplasms