Carcinoma, Small CellPhase 1/2NCT00359359
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
A Phase 1/2 study testing Sagopilone (BAY86-5302, ZK 219477) and Cisplatin in people with Carcinoma, Small Cell, run by Bayer at 10 sites in Germany.
Trial summary
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Small Cell
- What is being tested?
- Sagopilone (BAY86-5302, ZK 219477) and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 10 sitesGermany
- Study dates
- Jul 2006to Aug 2009
- Phase
- Phase 1/2
- 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
- Small-cell lung cancer
- Stage of extensive disease
- Adequate function of major organs and systems
- Use of highly effective birth control methods in females of child-bearing potential
Who cannot join
- Prior chemotherapy for small-cell lung cancer
- Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
- Superior vena cava syndrome or obstruction of any vital structure
- Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
- Known allergy or hypersensitivity to platinum-containing drugs
- Pregnancy or breast-feeding
- Use of any investigational drug within 4 weeks before start of the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Study site
Berlin, State of Berlin, 12200
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Frankfurt am Main, Hesse, 65929
Study site
Gerlingen, Baden-Wurttemberg, 70839
Study site
Hamburg, Free and Hanseatic City of Hamburg, 21075
Study site
Löwenstein, Baden-Wurttemberg, 74245
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
München, Bavaria, 80336
Study site
München, Bavaria, 81675
Study site
Wiesbaden, Hesse, 65199
About this study
Official title: Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their 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
- Carcinoma, Small Cell
- Being tested
- Sagopilone (BAY86-5302, ZK 219477), Cisplatin
- 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.
Sagopilone (BAY86-5302, ZK 219477)Drug
Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID
CisplatinDrug
75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Sagopilone and cisplatin | Experimental | The study drug sagopilone was administered in combination with a fixed dose of cisplatin Receives: Drug: Sagopilone (BAY86-5302, ZK 219477); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
Measured: Phase 1: Baseline up to 3 month of treatment
Phase 2: Efficacy measure
Measured: Phase 2: every 6 weeks after start of treatment
Secondary outcomes (5)
Phase 1: PK of Sagopilone + Cisplatin
Measured: Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
Phase 2: Duration of CR or PR
Duration of complete response (CR) or partial response (PR) as 'overall response', defined as time between first date that the measurement criteria for CR or PR as 'overall response' are met and first date that recurrence or overall response of (progressive disease) PD is documented.
Measured: every 6 weeks after start of treatment
Phase 2: TTP
Time to tumor progression (TTP) is defined as the time from the date of treatment assignment to the first observation of disease progression or to the last date of a definite assessment (not status unknown), if the patient is progression-free until that assessment.
Measured: every 6 weeks after start of treatment
Phase 2: PFS
Progression free survival (PFS) is defined as the time from date of treatment assignment to the first observation of disease progression or death of any cause or to the last date of a definite assessment (not status unknown), if the patient was progression-free until that assessment
Measured: every 6 weeks after start of treatment
Phase 2: OS
Overall survival (OS) is defined as the time from date of treatment assignment until death from any cause or until the last date the patient is known to be alive
Measured: every 3 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small CellStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT00359359
- Sponsor's protocol ID
- 91495
- Other IDs
- 2006-000067-29, 310101
- Status last verified
- Nov 2014
- First submitted
- 27 Jul 2006
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT00359359
- Acronym / sponsor ID
- 91495
- Conditions
- Carcinoma, Small Cell
- Keywords
- Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Aug 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 the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their 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 and cisplatin | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477), Drug: CisplatinThe study drug sagopilone was administered in combination with a fixed dose of cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Small-cell lung cancer
- Stage of extensive disease
- Adequate function of major organs and systems
- Use of highly effective birth control methods in females of child-bearing potential
Key exclusion criteria (7 listed)
- Prior chemotherapy for small-cell lung cancer
- Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
- Superior vena cava syndrome or obstruction of any vital structure
- Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
- Known allergy or hypersensitivity to platinum-containing drugs
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)Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID | Drug | Sagopilone and cisplatin |
| Cisplatin75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1 | Drug | Sagopilone and cisplatin |
Primary outcome
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
Time frame: Phase 1: Baseline up to 3 month of treatment
Phase 2: Efficacy measure
Time frame: Phase 2: every 6 weeks after start of treatment
5 secondary outcomes
Phase 1: PK of Sagopilone + Cisplatin
Time frame: Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion
Phase 2: Duration of CR or PR
Time frame: every 6 weeks after start of treatment
Phase 2: TTP
Time frame: every 6 weeks after start of treatment
Phase 2: PFS
Time frame: every 6 weeks after start of treatment
Phase 2: OS
Time frame: every 3 months after start of treatment
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 4 Nov 2014.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sagopilone (BAY86-5302, ZK 219477) and Cisplatin in people with Carcinoma, Small Cell, run by Bayer at 10 sites in Germany.
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 7 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 4 Nov 2014. 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin (time frame: Phase 1: Baseline up to 3 month of treatment). The study lists 2 primary outcomes in all. 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 4 Nov 2014.