Solid TumorsPhase 1NCT00720148
A Phase I Trial of Bortezomib and Sunitinib
A Phase 1 study testing Sunitinib and Bortezomib in people with Solid Tumors, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of the combination of sunitinib and bortezomib. We will see what effects it has on your cancer and find the highest dose of each agent that can be given without causing severe side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Sunitinib and Bortezomib
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 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
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Refractory advanced solid tumor that has failed standard therapy.
- ECOG PS ≤ 2
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Cardiac ejection fraction is more than 45%
Who cannot join
- Patient has a platelet count of <100 x 109/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of ANC <1.0 x 109/L within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment.
- AST, ALT, total bilirubin > twice the upper limits of normal.
- Received radiation to more than 30% of marrow volume
- Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
Show all 14Show fewer
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to sunitinib, bortezomib, boron or mannitol.
- Uncontrolled hypertension
- History of venous thromboembolic events.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Hemorrhagic tendency of the tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Phase IB Dose Escalation Study of Bortezomib (VELCADE) Administered Weekly for 4 Weeks and Sunitinib (SU-011248) Administered Daily for 4 Weeks Followed by a 14 Day Rest in Patients With Refractory Solid Tumors
The purpose of this study is to test the effect of the combination of sunitinib and bortezomib. We will see what effects it has on your cancer and find the highest dose of each agent that can be given without causing severe side effects.
Read the detailed description
This is a Phase I study assessing the combination of bortezomib and sunitinib in patients with solid tumors that are refractory to standard chemotherapy.
The study will take place in two stages. In both stages, patients will receive sunitinib orally with food once daily for 4 weeks and bortezomib by injection into a vein once a week for 4 weeks. This will be followed by 2 weeks of rest. This 6-week period is called one cycle.
In stage 1, a maximum of 10 patients will be treated sequentially with increasing doses of sunitinib (and a fixed dose of bortezomib). Each dose level must be well tolerated for the next patient to start treatment at the next dose level. Whichever is the highest dose of sunitinib that is well tolerated will then be used for the next stage.
In stage 2, a maximum of 20 patients will be treated sequentially with increasing doses of bortezomib (and a fixed dose of sunitinib). Each dose level must be well tolerated for the next patient to start treatment at the next dose level.
Together, the two stages will determine the highest doses of both sunitinib and bortezomib that are well tolerated when given this combination. Determining these optimal doses is the primary aim of this study. Patients will also be followed to see whether their tumor responds to the treatment.
If a patient's cancer remains stable or improves, they can repeat the treatment cycles. There is no defined end date to this study since patients will be followed for the duration of their survival.
- Conditions
- Solid Tumors
- Being tested
- Sunitinib and Bortezomib
- Keywords
- Solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunitinib and BortezomibDrug
Also called Sutent, Velcade
50 mg/m2, IV (in the vein)on day 5 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity of combination therapy with sunitinib and bortezomib
Measured: every week
Secondary outcomes (1)
Tumor shrinkage
Measured: every 6 weeks while on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Pfizer
- Responsible party
- Principal investigator, R. Donald Harvey, PharmD, Emory University
- Investigators
- John Kauh, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720148
- Sponsor's protocol ID
- IRB00003549
- Other IDs
- 3549
- Status last verified
- Aug 2014
- First submitted
- 18 Jul 2008
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Dose Escalation Study of Bortezomib (VELCADE) Administered Weekly for 4 Weeks and Sunitinib (SU-011248) Administered Daily for 4 Weeks Followed by a 14 Day Rest in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00720148
- Acronym / sponsor ID
- IRB00003549
- Conditions
- Solid Tumors
- Keywords
- Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Pfizer
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Jul 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 test the effect of the combination of sunitinib and bortezomib. We will see what effects it has on your cancer and find the highest dose of each agent that can be given without causing severe side effects.
Detailed description
This is a Phase I study assessing the combination of bortezomib and sunitinib in patients with solid tumors that are refractory to standard chemotherapy.
The study will take place in two stages. In both stages, patients will receive sunitinib orally with food once daily for 4 weeks and bortezomib by injection into a vein once a week for 4 weeks. This will be followed by 2 weeks of rest. This 6-week period is called one cycle.
In stage 1, a maximum of 10 patients will be treated sequentially with increasing doses of sunitinib (and a fixed dose of bortezomib). Each dose level must be well tolerated for the next patient to start treatment at the next dose level. Whichever is the highest dose of sunitinib that is well tolerated will then be used for the next stage.
In stage 2, a maximum of 20 patients will be treated sequentially with increasing doses of bortezomib (and a fixed dose of sunitinib). Each dose level must be well tolerated for the next patient to start treatment at the next dose level.
Together, the two stages will determine the highest doses of both sunitinib and bortezomib that are well tolerated when given this combination. Determining these optimal doses is the primary aim of this study. Patients will also be followed to see whether their tumor responds to the treatment.
If a patient's cancer remains stable or improves, they can repeat the treatment cycles. There is no defined end date to this study since patients will be followed for the duration of their survival.
Study design
- Primary purpose
- Treatment
- 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 (7 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Refractory advanced solid tumor that has failed standard therapy.
- ECOG PS ≤ 2
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Key exclusion criteria (14 listed)
- Patient has a platelet count of <100 x 109/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of ANC <1.0 x 109/L within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment.
- AST, ALT, total bilirubin > twice the upper limits of normal.
- Received radiation to more than 30% of marrow volume
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 |
|---|---|---|
| Sunitinib and BortezomibAlso: Sutent, Velcade50 mg/m2, IV (in the vein)on day 5 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops | Drug | – |
Primary outcome
Safety and toxicity of combination therapy with sunitinib and bortezomib
Time frame: every week
1 secondary outcome
Tumor shrinkage
Time frame: every 6 weeks while on treatment
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 Aug 2014.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
John Kauh, MD principal investigator
Emory University Winship Cancer Institute
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 Sunitinib and Bortezomib in people with Solid Tumors, run by Emory University at 1 site 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 7 inclusion and 14 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 Aug 2014. 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 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 toxicity of combination therapy with sunitinib and bortezomib (time frame: every week). 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 Aug 2014.