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Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Amrubicin hydrocloride

Docetaxel

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy
20 or older but younger than 75 years of age

Exclusion Criteria:

Symptomatic brain metastasis
Interstitial pneumonia or pulmonary fibrosis
Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
Active infection

Sites / Locations

32 Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 AMR

2 DOC

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival

response rate (RECIST)

Number of Participants with Adverse Events

Full Information

NCT ID

NCT01207011

First Posted

September 21, 2010

Last Updated

April 9, 2022

Sponsor

Sumitomo Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01207011

Brief Title

Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

Official Title

A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sumitomo Pharma Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 AMR

Arm Type

Experimental

Arm Title

2 DOC

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Amrubicin hydrocloride

Intervention Description

AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

3.3 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

12 months

Title

response rate (RECIST)

Time Frame

3 months

Title

Number of Participants with Adverse Events

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy 20 or older but younger than 75 years of age Exclusion Criteria: Symptomatic brain metastasis Interstitial pneumonia or pulmonary fibrosis Abnormal cardiac function or myocardial infraction within 6 months before study enrollment Active infection

Facility Information:

Facility Name

32 Sites

City

Multiple Locations

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28426104

Citation

Yoshioka H, Katakami N, Okamoto H, Iwamoto Y, Seto T, Takahashi T, Sunaga N, Kudoh S, Chikamori K, Harada M, Tanaka H, Saito H, Saka H, Takeda K, Nogami N, Masuda N, Harada T, Kitagawa H, Horio H, Yamanaka T, Fukuoka M, Yamamoto N, Nakagawa K. A randomized, open-label, phase III trial comparing amrubicin versus docetaxel in patients with previously treated non-small-cell lung cancer. Ann Oncol. 2017 Feb 1;28(2):285-291. doi: 10.1093/annonc/mdw621.

Results Reference

derived

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Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

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