NeoplasmsPhase 1NCT00606125
Sorafenib/ Carboplatin/ Paclitaxel in Patients With Solid Tumors
A Phase 1 study testing Nexavar (Sorafenib, 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 the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2. Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3. To determine the safety of sorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Nexavar (Sorafenib, BAY43-9006)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Feb 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 > or equal to 18 years
- Histological or cytological documentation of cancer, except non small cell lung cancer
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- No more than two prior chemotherapy regimens
- Adequate bone marrow, liver and renal function as assessed by the following:
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- Hemoglobin > or equal to 9.0 g/dL
- Absolute neutrophil count (ANC) > or equal to 1,500/mm3
- Platelet count > or equal to 100,000/mm3
- Total bilirubin < or equal to 1.25 times the ULN
- ALT and AST < or equal to 2.5 x ULN
- PT-INR/PTT < 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or low molecular weight heparin or therapeutically anticoagulated with LMWH will be allowed to participate provided that they meet these criteria; in addition, these patients must be monitored at appropriate intervals throughout study)
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 day period after last study drug dosing. The investigator should advise the patient regarding adequate means of contraception.
- Serum creatinine < or equal to 1.5 x upper limit of normal
- Ability to understand and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
Who cannot join
- Clinically evident congestive heart failure > NYHA Class 2 (See Appendix 10.4)
- Serious cardiac arrhythmias (for example requiring anti-arrhythmics)
- Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
- Active clinically serious infections (> Grade 2 NCI-CTC)
- Patients with history of brain metastases are eligible as long as the metastasis has been treated with either stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery or neurosurgery, patient does not require ongoing treatment with dexamethasone, the patient is not on anticoagulant therapy and whose radiographic imaging is stable ≥ 4 weeks from start of treatment. Time from brain metastasis treatment to first study treatment must meet the following criteria:
- Stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery ≥ 4 weeks from first study treatment
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- Neurosurgery ≥ 24 weeks from first study treatment
- Brain biopsy ≥ 12 weeks from first study treatment
- History of organ allograft
- 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 > or equal to Grade 2
- Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to Screening
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first study treatment
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first study treatment
- Evidence or history of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer, or bone fracture
- Patients undergoing renal dialysis
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
- Previous cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 3 years prior to first study treatment
- Non small cell lung cancer
- Ongoing substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Pregnant or breast-feeding patients.
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
New Haven, Connecticut, 06511-5991
Study site
San Antonio, Texas, 78229-3307
About this study
Official title: Phase I Study With Sorafenib in Combination With Carboplatin and Paclitaxel to Evaluate the Safety and Pharmacokinetics of This Combination in Patients With Solid Tumors
The purpose of this study is to:
- Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
- Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
- To determine the safety of sorafenib.
- Conditions
- Neoplasms
- Being tested
- Nexavar (Sorafenib, BAY43-9006)
- Keywords
- Chemotherapy, Solid Tumors, Sorafenib, Carboplatin, Paclitaxel
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexavar (Sorafenib, BAY43-9006)Drug
The purpose of this study is to: 1)evaluate how your body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2) measure your blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3) to determine the safety of sorafenib.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks
Measured: 2 years
Secondary outcomes (1)
To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionFeb 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
- 16 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
- NCT00606125
- Sponsor's protocol ID
- 11988
- Status last verified
- Jun 2014
- First submitted
- 21 Jan 2008
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study With Sorafenib in Combination With Carboplatin and Paclitaxel to Evaluate the Safety and Pharmacokinetics of This Combination in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00606125
- Acronym / sponsor ID
- 11988
- Conditions
- Neoplasms
- Keywords
- Chemotherapy, Solid Tumors, Sorafenib, Carboplatin, Paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 1 Feb 2008 (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:
- Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
- Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
- To determine the safety of sorafenib.
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: Nexavar (Sorafenib, BAY43-9006) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > or equal to 18 years
- Histological or cytological documentation of cancer, except non small cell lung cancer
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- No more than two prior chemotherapy regimens
Key exclusion criteria (28 listed)
- Clinically evident congestive heart failure > NYHA Class 2 (See Appendix 10.4)
- Serious cardiac arrhythmias (for example requiring anti-arrhythmics)
- Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
- Active clinically serious infections (> Grade 2 NCI-CTC)
- Patients with history of brain metastases are eligible as long as the metastasis has been treated with either stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery or neurosurgery, patient does not require ongoing treatment with dexamethasone, the patient is not on anticoagulant therapy and whose radiographic imaging is stable ≥ 4 weeks from start of treatment. Time from brain metastasis treatment to first study treatment must meet the following criteria:
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 |
|---|---|---|
| Nexavar (Sorafenib, BAY43-9006)The purpose of this study is to: 1)evaluate how your body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2) measure your blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3) to determine the safety of sorafenib. | Drug | Arm 1 |
Primary outcome
Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks
Time frame: 2 years
1 secondary outcome
To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel.
Time frame: 2 years
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 Jun 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
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 Nexavar (Sorafenib, 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 16 inclusion and 28 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 Jun 2014. 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?
Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks (time frame: 2 years). 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 Jun 2014.