Small Cell Lung CarcinomaPhase 2NCT00299390
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer
A Phase 2 study testing Sagopilone (BAY86-5302, ZK 219477) in people with Small Cell Lung Carcinoma, run by Bayer.
Trial summary
The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Sagopilone (BAY86-5302, ZK 219477)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Apr 2007
- 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
- Histologically or cytologically proven Small-cell lung cancer (SCLC)
- Stage of extensive disease defined by the presence of distant metastases
- At least 1 unidimensionally measureable lesion
- WHO performance status 0 to 1
- No previous SCLC-related chemotherapy
- No previous SCLC-related surgery
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- No previous radiotherapy (excepting for brain metastasis)
- Adequate function of major organs and systems
- Nervous system
- No Grade 2 or greater peripheral neuropathy
- Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No arrythmia needing continuous treatment
- No other uncontrolled concurrent illness
Who cannot join
- Superior vena cava syndrome or obstruction of any vital structure
- Untreated malignant hypercalcemia
- Pleural effusion as the only manifestation of disease
- Extensive disease amenable to radiation therapy
- Symptomatic brain metastases requiring whole brain irradiation
- Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix
About this study
Official title: Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)
The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Sagopilone (BAY86-5302, ZK 219477)
- Keywords
- Sagopilone, Epothilone, SCLC, Small Cell Lung Cancer, Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagopilone (BAY86-5302, ZK 219477)Drug
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| Sagopilone | Experimental | Not described Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment according to the modRECIST (complete response or partial response)
Measured: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Secondary outcomes (3)
Duration of complete or partial tumor response
Measured: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Time to tumor progression
Measured: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Number of participants with adverse events
Measured: Approximately 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299390
- Sponsor's protocol ID
- 91375
- Other IDs
- 2005-000597-53, 307972, 2005
- Status last verified
- Dec 2015
- First submitted
- 3 Mar 2006
- Last updated
- 31 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT00299390
- Acronym / sponsor ID
- 91375
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Sagopilone, Epothilone, SCLC, Small Cell Lung Cancer, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 6 Mar 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 determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sagopilone | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically proven Small-cell lung cancer (SCLC)
- Stage of extensive disease defined by the presence of distant metastases
- At least 1 unidimensionally measureable lesion
- WHO performance status 0 to 1
- No previous SCLC-related chemotherapy
Key exclusion criteria (6 listed)
- Superior vena cava syndrome or obstruction of any vital structure
- Untreated malignant hypercalcemia
- Pleural effusion as the only manifestation of disease
- Extensive disease amenable to radiation therapy
- Symptomatic brain metastases requiring whole brain irradiation
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 |
|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477)Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion | Drug | Sagopilone |
Primary outcome
Response to treatment according to the modRECIST (complete response or partial response)
Time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
3 secondary outcomes
Duration of complete or partial tumor response
Time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Time to tumor progression
Time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Number of participants with adverse events
Time frame: Approximately 30 weeks
Results and safety
The study was stopped early (reason given: Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sagopilone (BAY86-5302, ZK 219477) in people with Small Cell Lung Carcinoma, run by Bayer.
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 15 inclusion and 6 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 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .). 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?
Response to treatment according to the modRECIST (complete response or partial response) (time frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks). 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 31 Dec 2015.