Carcinoma, Renal CellPhase 2NCT00044564
Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
A Phase 2 study testing Bay 59-8862 in people with Carcinoma, Renal Cell, run by Bayer at 29 sites in 6 countries.
Trial summary
In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Bay 59-8862
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Dec 2001to Jan 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
Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - 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
29 sites in 6 countries.
29 sites in 6 countries
United States13 sites
Study site
Baltimore, Maryland, 21201-1595
Study site
Billings, Montana, 59101
Study site
Detroit, Michigan, 48201-9027
Study site
Greenbelt, Maryland, 20770
Study site
La Jolla, California, 92037
Study site
Milwaukee, Wisconsin, 53226
Study site
Muncie, Indiana, 47304
Study site
New Brunswick, New Jersey, 08901
Study site
New Orleans, Louisiana, 70121-2484
Study site
Salt Lake City, Utah, 84108
Study site
Southfield, Michigan, 48075
Study site
St Louis, Missouri, 63104
Study site
St Louis, Missouri, 63110
Germany6 sites
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
München, Bavaria, 81377
Study site
München, Bavaria, 81675
Study site
Münster, North Rhine-Westphalia, 48149
Study site
Tübingen, Baden-Wurttemberg, 72076
United Kingdom4 sites
Study site
Cardiff, South Glamorgan, CF14 2TL
Study site
Manchester, Greater Manchester, M20 4BX
Study site
Plymouth, Devon, PL6 8DH
Study site
Sutton, Surrey, SM2 5PT
Canada3 sites
Study site
Calgary, Alberta, T2N 4N2
Study site
Edmonton, Alberta, T6G 1Z2
Study site
Greater Sudbury, Ontario, P3E 5J1
About this study
Official title: An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Bay 59-8862
- Keywords
- Taxane, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bay 59-8862Drug
75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Bay 59-8862 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
Measured: At baseline and every 2 cycles during the treatment period
Secondary outcomes (8)
Duration of response
Measured: At baseline and every cycle during the treatment period
Overall survival
Measured: Till end of follow up period (up to 2 years)
Time to progression
Measured: Throughout study
Pharmacokinetics assessment
Measured: At cycle 1
Qualitative and quantitative toxicity profile
Measured: Day 1 of each cycle or as clinically indicated
Physical examinations
Measured: As clinically indicated
Vital signs data
Measured: Throughout study period
Abnormal laboratory tests
Measured: Prior to every cycle till last study visit
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 completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT00044564
- Sponsor's protocol ID
- 100386
- Status last verified
- Dec 2014
- First submitted
- 30 Aug 2002
- Last updated
- 19 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00044564
- Acronym / sponsor ID
- 100386
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Taxane, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Jan 2003 (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.
In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.
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: Bay 59-8862 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bay 59-886275 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal | Drug | Arm 1 |
Primary outcome
Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
Time frame: At baseline and every 2 cycles during the treatment period
8 secondary outcomes
Duration of response
Time frame: At baseline and every cycle during the treatment period
Overall survival
Time frame: Till end of follow up period (up to 2 years)
Time to progression
Time frame: Throughout study
Pharmacokinetics assessment
Time frame: At cycle 1
Qualitative and quantitative toxicity profile
Time frame: Day 1 of each cycle or as clinically indicated
Physical examinations
Time frame: As clinically indicated
Vital signs data
Time frame: Throughout study period
Abnormal laboratory tests
Time frame: Prior to every cycle till last study visit
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 19 Dec 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
29 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 Bay 59-8862 in people with Carcinoma, Renal Cell, run by Bayer at 29 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?
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 19 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 29 sites in United States, Germany, United Kingdom, Canada, France 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.
What does the primary outcome measure?
Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses (time frame: At baseline and every 2 cycles during the treatment period). 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 19 Dec 2014.