SCLCPhase 2NCT00046787
Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer
A Phase 2 study testing OSI-211 (Liposomal Lurtotecan) in people with SCLC and Carcinoma, Small Cell, run by Astellas Pharma Inc at 10 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Carcinoma, Small Cell
- What is being tested?
- OSI-211 (Liposomal Lurtotecan)
- How many people
- 47 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2002to Feb 2003
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed recurrent small cell lung cancer.
- One prior treatment of chemotherapy.
- At least three weeks since last chemotherapy treatment and recovery from any related side effects.
- At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects.
- At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan).
- If a patient has had previous documented Central Nervous System (CNS) involvement, only controlled disease is acceptable.
Who cannot join
- Superior vena cava syndrome.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom6 sites
Aberdeen Royal Infirmary
Aberdeen
Clatterbridge Centre for Oncology
Bebington, Wirral, CH63 4JY
Guys Hospital
London, SE1
Christie Hospital
Manchester, M20 9BH
Northern Centre for Cancer Research, Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB
United States4 sites
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Baptist Hospital Regional Cancer Ctr.
Knoxville, Tennessee, 37920
Vanderbilt Clinical Trials Office
Nashville, Tennessee, 37232-6307
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85712
About this study
Official title: Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer
The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.
- Conditions
- SCLC, Carcinoma, Small Cell
- Being tested
- OSI-211 (Liposomal Lurtotecan)
- Keywords
- Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Small Cell, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-211 (Liposomal Lurtotecan)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2002 (estimated)
- Study startSep 2002
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046787
- Sponsor's protocol ID
- 110-12
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2002
- Last updated
- 20 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00046787
- Acronym / sponsor ID
- 110-12
- Conditions
- SCLC, Carcinoma, Small Cell
- Keywords
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Study start
- Sep 2002
- Study completion
- Feb 2003 (actual)
- First posted
- 4 Oct 2002 (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 determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed recurrent small cell lung cancer.
- One prior treatment of chemotherapy.
- At least three weeks since last chemotherapy treatment and recovery from any related side effects.
- At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects.
- At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan).
Key exclusion criteria (1 listed)
- Superior vena cava syndrome.
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 |
|---|---|---|
| OSI-211 (Liposomal Lurtotecan) | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Oct 2011.
Related trials for SCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSI-211 (Liposomal Lurtotecan) in people with SCLC and Carcinoma, Small Cell, run by Astellas Pharma Inc at 10 sites in 2 countries.
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 6 inclusion and 1 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 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 20 Oct 2011.