Carcinoma, Non-Small-Cell LungPhase 2NCT00044538
Evaluation of BAY 59-8862 in Taxane Resistant Non-Small Cell Lung Cancer Patients
A Phase 2 study testing BAY59-8862 (Cytotoxic Taxane) in people with Carcinoma, Non-Small-Cell Lung, run by Bayer at 27 sites in 6 countries.
Trial summary
Lung cancer is among the most common cancers in the world and its incidence continues to increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under investigation for several decades and several new drugs with activity in NSCLC have been identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- BAY59-8862 (Cytotoxic Taxane)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Dec 2001to Jun 2004
- 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
- Measurable disease as defined by the presence of at least one measurable lesion
- Patients must have received at least 3 weeks of continuous therapy with Taxane - patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and kidney function
Who cannot join
- Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C; brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers
- excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant.
- others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
United States7 sites
Study site
Buffalo, New York, 14263-0001
Study site
Columbus, Ohio, 43235
Study site
Louisville, Kentucky, 40202
Study site
Metairie, Louisiana, 70006
Study site
Nashville, Tennessee, 37205
Study site
Tucson, Arizona, 85712
Study site
Waterbury, Connecticut, 06708-2904
Canada5 sites
Study site
Edmonton, Alberta, T6G 1Z2
Study site
Hamilton, Ontario, L8V 5C2
Study site
Montreal, Quebec, H3T 1E2
Study site
Québec, Quebec, G1V 4G5
Study site
Thunder Bay, Ontario, P7A 7T1
Italy5 sites
Study site
Modena, 41100
Study site
Parma, 43100
Study site
Pisa, 56126
Study site
Torino, 10126
Study site
Udine, 33100
Spain5 sites
Study site
Barakaldo, Bizkaia, 48903
Study site
Barcelona, Barcelona, 08036
Study site
Elche, Alicante, 03203
Study site
Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28040
Israel3 sites
Study site
Kfar Saba, 44281
Study site
Tel Aviv, 64239
Study site
Tel HaShomer, 52621
Germany2 sites
Study site
Berlin, State of Berlin, 13353
Study site
Gauting, Bavaria, 82131
About this study
Official title: An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
Lung cancer is among the most common cancers in the world and its incidence continues to increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under investigation for several decades and several new drugs with activity in NSCLC have been identified. These include the taxanes, which are among the most commonly used class of chemotherapy agents in clinical oncology today. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY 59-8862 will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant NSCLC.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BAY59-8862 (Cytotoxic Taxane)
- Keywords
- Taxane, Lung cancer, non-small cell, NSCLC
- 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.
BAY59-8862 (Cytotoxic Taxane)Drug
Intravenous dose over 60 minutes every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY59-8862 (Cytotoxic Taxane) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2002 (estimated)
- Study startDec 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044538
- Sponsor's protocol ID
- 10653
- Status last verified
- Jun 2009
- First submitted
- 30 Aug 2002
- Last updated
- 22 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
- ClinicalTrials.gov ID
- NCT00044538
- Acronym / sponsor ID
- 10653
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Taxane, Lung cancer, non-small cell, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Jun 2004 (actual)
- First posted
- 4 Sep 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.
Lung cancer is among the most common cancers in the world and its incidence continues to increase. Chemotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) has been under investigation for several decades and several new drugs with activity in NSCLC have been identified. These include the taxanes, which are among the most commonly used class of chemotherapy agents in clinical oncology today. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY 59-8862 will be conducted to determine the anti-tumor efficacy of BAY 59-8862 in taxane-resistant NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY59-8862 (Cytotoxic Taxane) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Measurable disease as defined by the presence of at least one measurable lesion
- Patients must have received at least 3 weeks of continuous therapy with Taxane - patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (3 listed)
- Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C; brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers
- excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant.
- others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
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 |
|---|---|---|
| BAY59-8862 (Cytotoxic Taxane)Intravenous dose over 60 minutes every 3 weeks | Drug | Arm 1 |
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 22 Jun 2009.
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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
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY59-8862 (Cytotoxic Taxane) in people with Carcinoma, Non-Small-Cell Lung, run by Bayer at 27 sites in 6 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 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: finished, as of the sponsor's last update on 22 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada, Italy, Spain, Israel and 1 more country. 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 22 Jun 2009.