Renal Cell Carcinoma 4NCT01370109
Cardiovascular Effects of Sunitinib Therapy (CREST)
An observational study of Renal Cell Carcinoma 4, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell carcinoma and have significant off-target effects with cardiac toxicity and resultant ventricular cardiac dysfunction being a major concern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma 4
- Type of treatment
- Pill or oral medicine
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 31 Dec 2017
- Phase
- Observational
- 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
Study population: Our target population is patients with renal cell carcinoma who are newly initiating therapy with the oral tyrosine-kinase inhibitor sunitinib.
Who may be able to join
- Patients with renal cell carcinoma newly undergoing therapy with sunitinib.
- Age greater than or equal to 18 years
- ECOG performance status 0,1,2
Who cannot join
- Any contraindication to sunitinib therapy of note, patients with prior cardiovascular history are not excluded from this study, as long as there are no contraindications to sunitinib therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Cardiovascular Effects of Sunitinib Therapy: Off Target Changes in Cardiac Metabolism and Ventricular Vascular Mechanics (CREST)
Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell carcinoma and have significant off-target effects with cardiac toxicity and resultant ventricular cardiac dysfunction being a major concern. However, the mechanisms of these effects in humans remains poorly defined, as are the clinical methods to risk stratify and identify patients who will ultimately suffer from cardiac dysfunction. The goal of this multi-center study is to characterize the cardiovascular measures of cardiac function; 2) comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers reflective of the pathophysiologic alterations. Through this work, the investigators will translate our basic understanding of sunitinib cardiotoxicity to humans and identify early predictors of sunitinib cardiotoxicity.
Read the detailed description
Tyrosine kinase inhibitors such as sunitinib have dramatically improved the overall management of certaincancers including renal cell carcinoma. However, recent data suggest that these therapieshave significant off-target effects with cardiac toxicity, including significant hypertension and ventricular cardiac dysfunction being a major concern. However, the biologic mechanisms underlying cardiotoxicty in humans remain poorly defined. Moreover, there is a critical need to develop methods to improve the risk stratification and early identification of patients who will suffer from hypertension and cardiac dysfunction with exposure to therapy. The over all objectives ofthis study are to further characterize the cardiovascular changes that occur with sunitinib exposure in order to improve our understanding of sunitib toxicity and determine early, mechanistically and clinically relevant predictors to identify patients at increased risk of hyptertension and cardiac dysfunction. The specific aims of this study are: 1) To define the changes in arterial hemodynamics that may occur with exposure to sunitinib, 2) To define the changes in sensitive echocardiographic measures of cardiac function that may occur with exposure to sunitinib, 3) To determine blood markers that are associated with changes in vasculature or cardiac function with exposure to sunitinib. and 4) To determine if there are early imaging or biomarker predictors of subitinib cardiotoxicity.
- Conditions
- Renal Cell Carcinoma 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Penn Site | Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks, with additional follow-up at 1 and 2 years. | |
| Vanderbilt University Medical Center | Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. | |
| Case Medical Center | Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. | |
| University of Wisconsin at Madison | Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Systolic Blood Pressure
Measured: 6 Months
Secondary outcomes (1)
Number of Participants with adverse events
Number of subjects with adverse events specifically, incident of hypertension and Cardiac dysfunction
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 posted9 Jun 2011 (estimated)
- Study startApr 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma 4Studies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonnie Ky, MD, Principal investigator, Abramson Cancer Center at the University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370109
- Sponsor's protocol ID
- UPCC 34810
- Status last verified
- Oct 2018
- First submitted
- 26 May 2011
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular Effects of Sunitinib Therapy: Off Target Changes in Cardiac Metabolism and Ventricular Vascular Mechanics (CREST)
- ClinicalTrials.gov ID
- NCT01370109
- Acronym / sponsor ID
- UPCC 34810
- Conditions
- Renal Cell Carcinoma 4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Jun 2011 (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.
Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell carcinoma and have significant off-target effects with cardiac toxicity and resultant ventricular cardiac dysfunction being a major concern. However, the mechanisms of these effects in humans remains poorly defined, as are the clinical methods to risk stratify and identify patients who will ultimately suffer from cardiac dysfunction. The goal of this multi-center study is to characterize the cardiovascular measures of cardiac function; 2) comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers reflective of the pathophysiologic alterations. Through this work, the investigators will translate our basic understanding of sunitinib cardiotoxicity to humans and identify early predictors of sunitinib cardiotoxicity.
Detailed description
Tyrosine kinase inhibitors such as sunitinib have dramatically improved the overall management of certaincancers including renal cell carcinoma. However, recent data suggest that these therapieshave significant off-target effects with cardiac toxicity, including significant hypertension and ventricular cardiac dysfunction being a major concern. However, the biologic mechanisms underlying cardiotoxicty in humans remain poorly defined. Moreover, there is a critical need to develop methods to improve the risk stratification and early identification of patients who will suffer from hypertension and cardiac dysfunction with exposure to therapy. The over all objectives ofthis study are to further characterize the cardiovascular changes that occur with sunitinib exposure in order to improve our understanding of sunitib toxicity and determine early, mechanistically and clinically relevant predictors to identify patients at increased risk of hyptertension and cardiac dysfunction. The specific aims of this study are: 1) To define the changes in arterial hemodynamics that may occur with exposure to sunitinib, 2) To define the changes in sensitive echocardiographic measures of cardiac function that may occur with exposure to sunitinib, 3) To determine blood markers that are associated with changes in vasculature or cardiac function with exposure to sunitinib. and 4) To determine if there are early imaging or biomarker predictors of subitinib cardiotoxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Penn Site | – | –Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks, with additional follow-up at 1 and 2 years. |
| Vanderbilt University Medical Center | – | –Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. |
| Case Medical Center | – | –Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. |
| University of Wisconsin at Madison | – | –Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our target population is patients with renal cell carcinoma who are newly initiating therapy with the oral tyrosine-kinase inhibitor sunitinib.
Key inclusion criteria (3 listed)
- Patients with renal cell carcinoma newly undergoing therapy with sunitinib.
- Age greater than or equal to 18 years
- ECOG performance status 0,1,2
Key exclusion criteria (1 listed)
- Any contraindication to sunitinib therapy of note, patients with prior cardiovascular history are not excluded from this study, as long as there are no contraindications to sunitinib therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Systolic Blood Pressure
Time frame: 6 Months
1 secondary outcome
Number of Participants with adverse events
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 2 Oct 2018.
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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.
Bonnie Ky, MD principal investigator
Abramson Cancer Center at the University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma 4, run by Abramson Cancer Center at Penn Medicine 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 3 inclusion and 1 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 2 Oct 2018. 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.
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?
Change from Baseline in Systolic Blood Pressure (time frame: 6 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 2 Oct 2018.