Non Small Cell Lung CancerPhase 2NCT00160043
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
A Phase 2 study testing SH T00268C and PTK787/ ZK 222584 in people with Non Small Cell Lung Cancer, run by Bayer at 6 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- SH T00268C and PTK787/ ZK 222584
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2005to Nov 2008
- 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
- Non small cell lung cancer, Stage IIIB or Stage IV
- One and only 1 prior platinum-based chemotherapy
- No other uncontrolled concurrent illness
- Use of highly effective birth control methods in males or females with reproductive potential
Who cannot join
- Previous participation in another trial within the last 4 weeks
- Surgery within 10 days prior to the start of study treatment
- Brain metastases
- Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
- Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
- Breast feeding
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France3 sites
Study site
Paris, 75651
Study site
Paris, 75970
Study site
Villejuif, 94805
Germany3 sites
Study site
Essen, North Rhine-Westphalia, 45122
Study site
Göttingen, Lower Saxony, 37075
Study site
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.
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
- Non Small Cell Lung Cancer
- Being tested
- SH T00268C, PTK787/ ZK 222584
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH T00268CDrug
1250 mg experimental drug od
PTK787/ ZK 222584Drug
1250 mg experimental drug bid (500mg + 750mg)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: SH T00268C |
| Arm 2 | Experimental | Not described Receives: Drug: PTK787/ ZK 222584 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate (complete or partial response according to RECIST).
Measured: At baseline and every 8 weeks afterwards
Secondary outcomes (1)
Time to disease progression.
Measured: At baseline and every 8 weeks afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2007
- Study completionNov 2008
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 Non Small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 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
- NCT00160043
- Sponsor's protocol ID
- 91411
- Other IDs
- 2004-002290-22, 308801, 2004
- Status last verified
- Dec 2014
- First submitted
- 9 Sep 2005
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.
PubMed 21617019
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00160043
- Acronym / sponsor ID
- 91411
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Sep 2005 (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 treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SH T00268C |
| Arm 2 | Experimental | Drug: PTK787/ ZK 222584 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non small cell lung cancer, Stage IIIB or Stage IV
- One and only 1 prior platinum-based chemotherapy
- No other uncontrolled concurrent illness
- Use of highly effective birth control methods in males or females with reproductive potential
Key exclusion criteria (6 listed)
- Previous participation in another trial within the last 4 weeks
- Surgery within 10 days prior to the start of study treatment
- Brain metastases
- Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
- Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
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 |
|---|---|---|
| SH T00268C1250 mg experimental drug od | Drug | Arm 1 |
| PTK787/ ZK 2225841250 mg experimental drug bid (500mg + 750mg) | Drug | Arm 2 |
Primary outcome
Tumor response rate (complete or partial response according to RECIST).
Time frame: At baseline and every 8 weeks afterwards
1 secondary outcome
Time to disease progression.
Time frame: At baseline and every 8 weeks afterwards
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 16 Dec 2014.
- Results publication: PubMed 21617019Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.
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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
6 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 SH T00268C and PTK787/ ZK 222584 in people with Non Small Cell Lung Cancer, run by Bayer at 6 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 4 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: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, 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 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.
What does the primary outcome measure?
Tumor response rate (complete or partial response according to RECIST). (time frame: At baseline and every 8 weeks afterwards). 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 NCT00160043, 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 16 Dec 2014.