Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer
NCT ID: NCT01207011
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2010-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 AMR
Amrubicin hydrocloride
AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.
2 DOC
Docetaxel
DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.
Interventions
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Amrubicin hydrocloride
AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.
Docetaxel
DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.
Eligibility Criteria
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Inclusion Criteria
* 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy
* 20 or older but younger than 75 years of age
Exclusion Criteria
* Interstitial pneumonia or pulmonary fibrosis
* Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
* Active infection
20 Years
74 Years
ALL
No
Sponsors
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Sumitomo Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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32 Sites
Multiple Locations, , Japan
Countries
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References
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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.
Other Identifiers
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D0702035
Identifier Type: -
Identifier Source: org_study_id
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