CancerPhase 1NCT00562913
Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin
A Phase 1 study testing Nexavar (Sorafenib, BAY43-9006) in people with Cancer, run by Bayer at 2 sites in Canada.
Trial summary
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nexavar (Sorafenib, BAY43-9006)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2007to Mar 2010
- 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
- At least 18 years old
- Advanced histological or cytological documentation of cancer
- life-expectancy of at least 12 weeks
- able to swallow pills
- ECOG status of 0,1 or 2
- adequate bone marrow
- liver and renal function
Who cannot join
- > NYHA Class 2 CHF
- Serious myocardial dysfunction,
- or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
- History of organ allograft
- uncontrolled hypertension
- renal dialysis
Show all 9Show fewer
- Bleeding event/hemorrhage within 4 weeks of study treatment
- major surgery within 4 weeks of study treatment
- Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Study site
Edmonton, Alberta, T6G 1Z2
Study site
Montreal, Quebec, H3T 1E2
About this study
Official title: Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients
- Conditions
- Cancer
- Being tested
- Nexavar (Sorafenib, BAY43-9006)
- Keywords
- Cancer, Sorafenib, Cyclophosphamide, Doxorubicin
- 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
Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin
| 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.
To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
Measured: 6 weeks
Secondary outcomes (1)
To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib
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 posted26 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 21 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
- NCT00562913
- Sponsor's protocol ID
- 12347
- Status last verified
- Nov 2013
- First submitted
- 21 Nov 2007
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00562913
- Acronym / sponsor ID
- 12347
- Conditions
- Cancer
- Keywords
- Cancer, Sorafenib, Cyclophosphamide, Doxorubicin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 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.
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients
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 (7 listed)
- At least 18 years old
- Advanced histological or cytological documentation of cancer
- life-expectancy of at least 12 weeks
- able to swallow pills
- ECOG status of 0,1 or 2
Key exclusion criteria (9 listed)
- > NYHA Class 2 CHF
- Serious myocardial dysfunction,
- or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
- History of organ allograft
- uncontrolled hypertension
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)Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin | Drug | Arm 1 |
Primary outcome
To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
Time frame: 6 weeks
1 secondary outcome
To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib
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 26 Nov 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 Nexavar (Sorafenib, BAY43-9006) in people with Cancer, run by Bayer at 2 sites in Canada.
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 7 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 26 Nov 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 Canada. 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 pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered (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 26 Nov 2013.