Lung CancerPhase 3NCT01207011
Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer
A Phase 3 study testing Amrubicin hydrocloride and Docetaxel in people with Lung Cancer, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Amrubicin hydrocloride and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2010to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Symptomatic brain metastasis
- Interstitial pneumonia or pulmonary fibrosis
- Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
- Active infection
Trial locations and contacts
1 site in 1 country.
About this study
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
The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).
- Conditions
- Lung Cancer
- Being tested
- Amrubicin hydrocloride, Docetaxel
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amrubicin hydroclorideDrug
AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.
DocetaxelDrug
DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.
| Study group | Role | What they receive |
|---|---|---|
| 1 AMR | Experimental | Not described Receives: Drug: Amrubicin hydrocloride |
| 2 DOC | Active comparator | Not described Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 3.3 months
Secondary outcomes (3)
Overall survival
Measured: 12 months
response rate (RECIST)
Measured: 3 months
Number of Participants with Adverse Events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207011
- Sponsor's protocol ID
- D0702035
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2010
- Last updated
- 12 Apr 2022
- Results posted
- No
Publications
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.
PubMed 28426104
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01207011
- Acronym / sponsor ID
- D0702035
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 AMR | Experimental | Drug: Amrubicin hydrocloride |
| 2 DOC | Active comparator | Drug: Docetaxel |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Symptomatic brain metastasis
- Interstitial pneumonia or pulmonary fibrosis
- Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amrubicin hydroclorideAMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course. | Drug | 1 AMR |
| DocetaxelDOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course. | Drug | 2 DOC |
Primary outcome
Progression free survival
Time frame: 3.3 months
3 secondary outcomes
Overall survival
Time frame: 12 months
response rate (RECIST)
Time frame: 3 months
Number of Participants with Adverse Events
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 28426104Yoshioka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amrubicin hydrocloride and Docetaxel in people with Lung Cancer, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 3.3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.