NeoplasmsPhase 1NCT00562523
Sorafenib/Docetaxel Dose Escalation Trial
A Phase 1 study testing Sorafenib (Nexavar, BAY43-9006) in people with Neoplasms, run by Bayer at 2 sites in United States.
Trial summary
The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Mar 2009
- Phase
- Phase 1
- 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 greater than or equal to 18 years
- Advanced histological or cytological documentation of cancer
- At least one evaluable lesion
- ECOG Performance Status of 0 or 1
- No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
- Life expectancy of at least 12 weeks
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- No previous exposure to docetaxel or sorafenib
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin greater than or equal to 9.0 g/dL
- Absolute neutrophil count (ANC) greater than or equal to 2,500/mm3
- Platelet count greater than or equal to 100,000/mm3 Hepatic
- Total Bilirubin less than or equal to ULN
- AST, ALT and Alkaline Phosphatase less than 1.5x ULN.
- PT-INR/PTT less than 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or heparin will be allowed to participate provided that the INR less than 1.5. In addition, these patients must be monitored at appropriate intervals throughout study)
- Serum creatinine less than or equal to 1.5 x upper limit of normal
Who cannot join
- Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
- Active clinically serious infections (> Grade 2 NCI-CTCAE Version 3.0)
- Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Peripheral neuropathy > Grade 1
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- Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to screening
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
- Pregnant or breast feeding women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Philadelphia, Pennsylvania, 19111-2497
Study site
Tampa, Florida, 33612
About this study
Official title: A Phase I Dose Escalation Study With Sorafenib Administered Continuously in Combination With Docetaxel Administered Once Every Three Weeks in Patients With Advanced Solid Tumors.
The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.
- Conditions
- Neoplasms
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Cancer, Docetaxel, Sorafenib
- Medical subject headings
- 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
Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
Measured: 6 weeks
Secondary outcomes (1)
To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562523
- Sponsor's protocol ID
- 12438
- Status last verified
- May 2013
- First submitted
- 21 Nov 2007
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study With Sorafenib Administered Continuously in Combination With Docetaxel Administered Once Every Three Weeks in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT00562523
- Acronym / sponsor ID
- 12438
- Conditions
- Neoplasms
- Keywords
- Cancer, Docetaxel, Sorafenib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Nov 2007 (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: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.
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: Sorafenib (Nexavar, BAY43-9006) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age greater than or equal to 18 years
- Advanced histological or cytological documentation of cancer
- At least one evaluable lesion
- ECOG Performance Status of 0 or 1
- No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
Key exclusion criteria (9 listed)
- Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
- Active clinically serious infections (> Grade 2 NCI-CTCAE Version 3.0)
- Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
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)Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks | Drug | Arm 1 |
Primary outcome
To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
Time frame: 6 weeks
1 secondary outcome
To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together
Time frame: 6 weeks
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 23 May 2013.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib (Nexavar, BAY43-9006) in people with Neoplasms, run by Bayer at 2 sites in United States.
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 15 inclusion and 9 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 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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.
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?
To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib (time frame: 6 weeks). 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 23 May 2013.