NCT01207011

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3 lung-cancer

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

3.7 years

First QC Date

September 21, 2010

Last Update Submit

April 9, 2022

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    3.3 months

Secondary Outcomes (3)

  • Overall survival

    12 months

  • response rate (RECIST)

    3 months

  • Number of Participants with Adverse Events

    4 months

Study Arms (2)

1 AMR

EXPERIMENTAL
Drug: Amrubicin hydrocloride

2 DOC

ACTIVE COMPARATOR
Drug: Docetaxel

Interventions

Amrubicin hydroclorideDRUG

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

1 AMR
DocetaxelDRUG

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

2 DOC

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

32 Sites

Multiple Locations, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28426104DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

JP(1)