Amrubicin Study for Elderly Patients With Extensive-disea... | NCT00286169

Studies
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

NCT00286169

Sponsor

Sumitomo Pharma Co., Ltd.

Status

Terminated

Last Update Posted

Apr 12, 2022Actual

Enrollment

130Estimated

Phase

Phase 3

Conditions

Small-cell Lung Cancer

Interventions

Amrubicin Hydrochloride

Countries

Japan

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

ID	Type	Description	Link
JapicCTI-060203

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 3, 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

Apr 9, 2022

Last Update Posted Date

Apr 12, 2022Actual

Description Module

Brief Summary

The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Name	Type	Description	Arm Group Labels	Other Names
Amrubicin Hydrochloride	Drug

Measure	Description	Time Frame
Overall survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Extensive-disease small-cell lung cancer
Aged 70 years or older
Performance status of 0-2
No prior chemotherapy

Exclusion Criteria:

Prior therapy for primary lesion
Pneumonitis and/or pulmonary fibrosis
Active concomitant malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Drug Development Division	Sumitomo Pharma Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chugoku Region Site		Chugoku			Japan
Chubu Region Site

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Time to progression
Objective tumor response
Quality of Life (QOL: EuroQOL, FACT-L-LCS)