Carcinoma, Renal CellPhase 2NCT00079612
Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 7 sites in 2 countries.
Trial summary
The purpose of the study is to: Find out if BAY 43-9006 prevents the growth of tumors For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. 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?
- Sorafenib (Nexavar, BAY43-9006)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 501 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2002to Jan 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
- Age > 18 years- Patients with refractory solid cancer for which curative or palliative measures have failed or patients whose treatments are considered ineffective or intolerable
- Patients with non-colorectal cancers are eligible and must be progressing at the time of the screening assessment and for whom no other treatment exists
- Patients with at least one (1) measurable tumor, per the WHO Tumor Response Criteria - Histological or cytological documentation of cancer- ECOG Performance status 0 or 1
- Life expectancy of at least 12 weeks- Adequate bone marrow, liver and renal function (assessed by the following laboratory requirements):
- Hemoglobin >/= 9.0 g/dl - Absolute neutrophil count (ANC) >/=1,500/mm3
- Platelet count = 100,000/µl3
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- Total bilirubin </=1.0 times the upper limit of normal unless due to Gilbert's
- ALT and AST </= 2.5 x upper limit of normal. (For patients with hepatic involvement of their cancer, ALT and AST < 5.0 x upper limit of normal)
- PT-INR/PTT < 1.5 x upper limit of normal. (Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
- In addition, these patients must be monitored with weekly coagulation assessments throughout the Run-in Period)- Serum creatinine < 1.5 x upper limit of normal
Who cannot join
- Patients who meet the following criteria at the time of screening will be excluded:
- Non small cell lung cancer, hepatocellular cancer, CML and AML
- Serious cardiac arrhythmia
- Congestive Heart Failure (NYHA Class 3 or 4)
- Active of coronary artery disease or ischemia
- Active acute infections that could be worsened by anticancer therapy or interfere with this study
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- Known HIV infection
- Metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
- Patients currently receiving medication (steroid or anticonvulsant therapy) for seizure disorder
- History of organ allograft- Previous or concurrent cancer that is distinct from the cancer being evaluated in this study. Several situations are excluded, including cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors or any cancer definitively treated greater than 3 years
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of study drug
- Radiotherapy during the study or within 3 weeks prior to the first dose of study drug
- Bone marrow transplant or stem cell rescue within 4 months prior to the first dose of study drug
- Biological response modifiers, such as G-CSF within 3 weeks prior to study entry
- Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study
- Investigational drug therapy outside of this trial during or within 4 weeks prior to the screening assessment
- Any previous exposure to a Ras pathway inhibitor
- Pregnant or breast feeding patients. Women of child bearing potential must have a negative pregnancy test. Adequate barrier contraception will be required for both male and female patients during the entire course of the trial
- Substance abuse, medical or psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Known or suspected allergy to the investigational agent or any agent given in association with the trial
- Any condition that is unstable or could jeopardize the safety of the patient and/or their compliance in the study
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Study site
Chicago, Illinois, 60637
Study site
Houston, Texas, 77030
Study site
Philadelphia, Pennsylvania, 19104
Study site
San Antonio, Texas, 78229
United Kingdom3 sites
Study site
Glasgow, Strathclyde, G11 6NT
Study site
London, Greater London, SW3 6JJ
Study site
Sutton, Surrey, SM2 5PT
About this study
Official title: Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.
The purpose of the study is to:
- Find out if BAY 43-9006 prevents the growth of tumors
- For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
- Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
- Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sorafenib (Nexavar, BAY43-9006), Placebo
- Keywords
- Renal Cell Cancer, RCC, Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
800mg daily (2x 400mg tabs)
PlaceboDrug
2x 400mg tabs daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of progressions post randomization to placebo or sorafenib
Measured: 12 weeks post randomization
Secondary outcomes (3)
Time to progression
Measured: Until Progression occurs
Duration of objective tumor response
Measured: Time from initial Response to documented Tumor Progression
Overall survival time
Measured: At the End-of-Study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2004 (estimated)
- Study startSep 2002
- Study completionJan 2007
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079612
- Sponsor's protocol ID
- 100391
- Status last verified
- Dec 2014
- First submitted
- 9 Mar 2004
- 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
- Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.
- ClinicalTrials.gov ID
- NCT00079612
- Acronym / sponsor ID
- 100391
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Renal Cell Cancer, RCC, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Sep 2002
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Mar 2004 (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:
- Find out if BAY 43-9006 prevents the growth of tumors
- For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
- Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
- Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years- Patients with refractory solid cancer for which curative or palliative measures have failed or patients whose treatments are considered ineffective or intolerable
- Patients with non-colorectal cancers are eligible and must be progressing at the time of the screening assessment and for whom no other treatment exists
- Patients with at least one (1) measurable tumor, per the WHO Tumor Response Criteria - Histological or cytological documentation of cancer- ECOG Performance status 0 or 1
- Life expectancy of at least 12 weeks- Adequate bone marrow, liver and renal function (assessed by the following laboratory requirements):
- Hemoglobin >/= 9.0 g/dl - Absolute neutrophil count (ANC) >/=1,500/mm3
Key exclusion criteria (21 listed)
- Patients who meet the following criteria at the time of screening will be excluded:
- Non small cell lung cancer, hepatocellular cancer, CML and AML
- Serious cardiac arrhythmia
- Congestive Heart Failure (NYHA Class 3 or 4)
- Active of coronary artery disease or ischemia
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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)800mg daily (2x 400mg tabs) | Drug | Arm 1 |
| Placebo2x 400mg tabs daily | Drug | Arm 2 |
Primary outcome
Number of progressions post randomization to placebo or sorafenib
Time frame: 12 weeks post randomization
3 secondary outcomes
Time to progression
Time frame: Until Progression occurs
Duration of objective tumor response
Time frame: Time from initial Response to documented Tumor Progression
Overall survival time
Time frame: At the End-of-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.
- #PL#J CLIN ONCOL 24 (16) 2505-2512 (2006)Link provided by the sponsor.
- #PL#PubMed.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
7 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 Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 7 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 10 inclusion and 21 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 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 7 sites in United States, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Number of progressions post randomization to placebo or sorafenib (time frame: 12 weeks post randomization). 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.