Advanced Solid TumorPhase 1NCT00509613
Phase 1 Study With Sorafenib and Sirolimus
A Phase 1 study testing Sorafenib and Sirolimus in people with Advanced Solid Tumor and Refractory to Standard Therapies, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Refractory to Standard Therapies
- What is being tested?
- Sorafenib and Sirolimus
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Jun 2007to May 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
- Patients with histological or cytological confirmed advanced solid tumor, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a combination of sorafenib and sirolimus (especially metastic RCC, malignant melanoma, HCC, NSCLC, pancreatic cancer, hormone refractory prostate cancer).
- Men or women of at least 18 years
- Patients who have an ECOG status of 0 or 1
- Patients who have a life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function
- Negative pregnancy test for female patients of childbearing potential
- Women and men enrolled into this trial must use adequate birth control measures during the course of the trial.
- Signed informed consent
Who cannot join
- History of serious cardiac disease
- Active clinically serious bacterial, viral or fungal infections (> grade 2).
- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
- Clinically symptomatic brain or meningeal metastasis.
- Patients with seizure disorders requiring medication (such as steroids or antiepileptics).
- Patients with evidence or history of bleeding diathesis.
- Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.
- Concomitant treatment with strong CYP3A4 inductors (such as rifampicin, St. John´s Wort) or CYP3A4 inhibitors (such as ketoconazole, voriconazole, itraconazole, diltiazem, verapamil, erythromycin). Moderate or weak CYP3A4 modifiers should be used concomitantly only after careful assessment of risk-benefit ratio. Concomitant use of carbamazepine, phenobarbital, phenytoin or chronic use of dexamethasone is excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor
The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies
Secondary outcomes (4)
to determine the safety profile of the combination therapy of sorafenib with sirolimus
to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy
to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus
to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- C.M.L. van Herpen, MD, PhD, Principal investigator, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509613
- Sponsor's protocol ID
- UMCNONCO 2006_01
- Other IDs
- 2006-006454-10
- Status last verified
- Sep 2009
- First submitted
- 30 Jul 2007
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT00509613
- Acronym / sponsor ID
- UMCNONCO 2006_01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jun 2007
- Primary completion
- May 2009 (actual)
- First posted
- 31 Jul 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 the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histological or cytological confirmed advanced solid tumor, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a combination of sorafenib and sirolimus (especially metastic RCC, malignant melanoma, HCC, NSCLC, pancreatic cancer, hormone refractory prostate cancer).
- Men or women of at least 18 years
- Patients who have an ECOG status of 0 or 1
- Patients who have a life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function
Key exclusion criteria (8 listed)
- History of serious cardiac disease
- Active clinically serious bacterial, viral or fungal infections (> grade 2).
- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
- Clinically symptomatic brain or meningeal metastasis.
- Patients with seizure disorders requiring medication (such as steroids or antiepileptics).
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 | Drug | – |
| Sirolimus | Drug | – |
Primary outcome
identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies
4 secondary outcomes
to determine the safety profile of the combination therapy of sorafenib with sirolimus
to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy
to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus
to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases)
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 18 Sep 2009.
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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.
C.M.L. van Herpen, MD, PhD principal investigator
UMC St Radboud
1 site 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 and Sirolimus in people with Advanced Solid Tumor and Refractory to Standard Therapies, run by Radboud University Medical Center at 1 site in Netherlands.
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 8 inclusion and 8 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies. 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 18 Sep 2009.