Carcinoma, Renal CellPhase 2NCT00854620
Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
A Phase 2 study testing Sorafenib in people with Carcinoma, Renal Cell and Kidney Disease, run by Stanford University at 1 site in United States.
Trial summary
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Carcinoma, Renal Cell, Kidney Disease, Kidney Cancer
- What is being tested?
- Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
- must have a component of conventional clear cell renal carcinoma.
- No more than one prior systemic therapy.
- No prior vascular endothelial growth factor receptor agents.
- Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.
- All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to Day 1 dosing. Patients must have recovered from surgery and/or radiotherapy toxicity prior to Day 1 dosing.
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- Measureable disease by RECIST criteria
- Karnofsky performance status at least 70% or ECOG not more than 2
- Ability to give written informed consent
- At least 18 years old
- Negative pregnancy test within 7 days of Day 1 dosing (female subjects of childbearing potential)
- Sexually active fertile subjects must agree to use an accepted method of contraception during the course of the study for 3 months thereafter.
- ANC at least 1,500/uL
- Platelet count at least 100,000/uL
- AST/ALT not more than 2.5 times the upper limit of normal (ULN)
- Alkaline phosphatase not more than 2.5 x ULN
- Serum bilirubin not more than 1.5 x ULN
- Amylase/Lipase within normal range
- Urinalysis not more than 1+ protein
- Serum creatinine not more than 1.5 x ULN
- No active ischemia by ECG
- Echocardiogram or MUGA ejection fraction at least 40%
Who cannot join
- Ongoing hemoptysis
- Cerebrovascular accident within 12 months
- Peripheral vascular disease with claudication on less than 1 block
- History of clinically significant bleeding
- Malignancy with true papillary/sarcomatoid features without any clear cell component
- Chromophobe
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- Oncocytoma
- Collecting duct tumors
- Transitional cell carcinoma
- Deep venous thrombosis or pulmonary embolus within one year of consent
- Ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed
- Subjects with evidence of current central nervous system (CNS) metastases
- MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to Day 1 dosing
- Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, II or IV)
- Angina pectoris requiring nitrate therapy
- Myocardial infarction within the last 6 months
- Uncontrolled hypertension (defined as blood pressure at least 160 mmHg systolic or at least 90 mmHg diastolic on medication)
- Ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency). Topical and/or inhaled steroids are allowed.
- Uncontrolled psychiatric disorder
- Delayed healing of wounds, ulcers, and/or bone fractures
- Prior malignancy (EXCEPTIONS: adequately-treated basal cell or squamous cell skin cancer or any other cancer for which chemotherapy has been completed > 5 years ago and from which the patient has been disease-free for > 5 years)
- Pregnant
- Currently lactating
- Currently using St John's Wort (an herb)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
Read the detailed description
Sorafenib to be administered as 28-day cycles.
Sorafenib dose escalation by cycle is:
- Cycle 1: 400 mg BID
- Cycle 2: 600 mg BID
- Cycle 3+: 800 mg BID
Within subject dose escalation and maximum dose is dependent on observed tolerability.
Dose escalation only occurs after acceptable tolerability is demonstrated by subject.
- Conditions
- Carcinoma, Renal Cell, Kidney Disease, Kidney Cancer
- Being tested
- Sorafenib
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar, Sorafenib tosylate
Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | * Cycle 1: 400 mg BID sorafenib
* Cycle 2: 600 mg BID sorafenib
* Cycle 3+: 800 mg BID sorafenib Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-progression (TTP)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionJul 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Stanford 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Srinivas, Stanford University
- Investigators
- Dr. Sandy Srinivas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854620
- Sponsor's protocol ID
- IRB-04988
- Other IDs
- 96919, SU-02272009-1898, RENAL0009
- Status last verified
- May 2015
- First submitted
- 27 Feb 2009
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University
- ClinicalTrials.gov ID
- NCT00854620
- Acronym / sponsor ID
- IRB-04988
- Conditions
- Carcinoma, Renal Cell, Kidney Disease, Kidney Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Posted 14 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib
Detailed description
Sorafenib to be administered as 28-day cycles.
Sorafenib dose escalation by cycle is:
- Cycle 1: 400 mg BID
- Cycle 2: 600 mg BID
- Cycle 3+: 800 mg BID
Within subject dose escalation and maximum dose is dependent on observed tolerability.
Dose escalation only occurs after acceptable tolerability is demonstrated by subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: Sorafenib* Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically- or cytologically-confirmed metastatic or unresectable renal cell carcinoma (RCC).
- must have a component of conventional clear cell renal carcinoma.
- No more than one prior systemic therapy.
- No prior vascular endothelial growth factor receptor agents.
- Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided the subject has at least one measurable and/or evaluable lesion(s) that has not been irradiated.
Key exclusion criteria (24 listed)
- Ongoing hemoptysis
- Cerebrovascular accident within 12 months
- Peripheral vascular disease with claudication on less than 1 block
- History of clinically significant bleeding
- Malignancy with true papillary/sarcomatoid features without any clear cell component
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 |
|---|---|---|
| SorafenibAlso: Nexavar, Sorafenib tosylateSorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID) | Drug | Sorafenib |
Primary outcome
Time-to-progression (TTP)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dr. Sandy Srinivas principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Carcinoma, Renal Cell and Kidney Disease, run by Stanford 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 22 inclusion and 24 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 19 Jun 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-to-progression (TTP) (time frame: 12 months). 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 19 Jun 2015.