Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer
April 9, 2022 updated by: Sumitomo Pharma Co., Ltd.
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
The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
202
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Multiple Locations, Japan
- 32 Sites
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 AMR
|
AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.
|
|
Active Comparator: 2 DOC
|
DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression free survival
Time Frame: 3.3 months
|
3.3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 12 months
|
12 months
|
|
Number of Participants with Adverse Events
Time Frame: 4 months
|
4 months
|
|
response rate (RECIST)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 21, 2010
First Submitted That Met QC Criteria
September 21, 2010
First Posted (Estimate)
September 22, 2010
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 9, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0702035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.