Small-cell Lung CancerPhase 3NCT00286169
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
A Phase 3 study testing Amrubicin Hydrochloride in people with Small-cell Lung Cancer, run by Sumitomo Pharma Co., Ltd. at 8 sites in Japan.
Trial summary
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- Amrubicin Hydrochloride
- How many people
- 130 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2006to not given
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Extensive-disease small-cell lung cancer
- Aged 70 years or older
- Performance status of 0-2
- No prior chemotherapy
Who cannot join
- Prior therapy for primary lesion
- Pneumonitis and/or pulmonary fibrosis
- Active concomitant malignancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Chubu Region Site
Chūbu
Chugoku Region Site
Chugoku
Hokkaido Region Site
Hokkaido
Kanto Region Site
Kanto
Kinki Region Site
Kinki
Kyushu Region Site
Kyushu
Shikoku Region Site
Shikoku
Tohoku Region Site
Tōhoku
About this study
Official title: Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.
- Conditions
- Small-cell Lung Cancer
- Being tested
- Amrubicin Hydrochloride
- Keywords
- Extensive-disease small-cell lung cancer (ED-SCLC)
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amrubicin HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (4)
Time to progression
Objective tumor response
Quality of Life (QOL: EuroQOL, FACT-L-LCS)
Frequency and severity of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Drug Development Division, Study director, Sumitomo Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286169
- Sponsor's protocol ID
- D0702002
- Other IDs
- JapicCTI-060203
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2006
- Last updated
- 12 Apr 2022
- Results posted
- No
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
- Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00286169
- Acronym / sponsor ID
- D0702002
- Conditions
- Small-cell Lung Cancer
- Keywords
- Extensive-disease small-cell lung cancer (ED-SCLC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- First posted
- 3 Feb 2006 (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 purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Extensive-disease small-cell lung cancer
- Aged 70 years or older
- Performance status of 0-2
- No prior chemotherapy
Key exclusion criteria (3 listed)
- Prior therapy for primary lesion
- Pneumonitis and/or pulmonary fibrosis
- Active concomitant malignancy
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 Hydrochloride | Drug | – |
Primary outcome
Overall survival
4 secondary outcomes
Time to progression
Objective tumor response
Quality of Life (QOL: EuroQOL, FACT-L-LCS)
Frequency and severity of adverse events
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Drug Development Division study director
Sumitomo Pharma Co., Ltd.
8 sites 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 Hydrochloride in people with Small-cell Lung Cancer, run by Sumitomo Pharma Co., Ltd. at 8 sites 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 4 inclusion and 3 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: stopped early, 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 8 sites 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 was stopped early. Results are not available in the source record.
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?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.