Adult Solid NeoplasmPhase 1NCT00499135
Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors
A Phase 1 study testing Computed Tomography, Fluorothymidine F-18 and Laboratory Biomarker Analysis in people with Adult Solid Neoplasm and Clear Cell Renal Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Solid Neoplasm, Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma
- What is being tested?
- Computed Tomography, Fluorothymidine F-18 and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2007to 14 May 2014
- 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 must have histologically or cytologically confirmed renal cell cancer; or other solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which no standard curative therapy exists
- For the renal cell cancer subset, a component of clear cell histology is required
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
- Life expectancy > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Leukocytes >= 3,000/mm^3
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- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dL
- Serum calcium =< 12.0 mg/dL
- Total bilirubin normal
- Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times upper limit of normal (ULN), unless subjects have liver metastases, in which case both AST and ALT must be =< 5 x ULN
- Creatinine =< 2 times ULN OR creatinine clearance >= 40 mL/min for patients with creatinine levels above 2 x institutional normal
- All patients need to be willing to undergo planned pharmacodynamic assessments, including serial PET imaging, plasma markers, and pharmacokinetic sampling
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had chemotherapy, radiotherapy, experimental therapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered (to grade < 1 or baseline) from clinically significant adverse events due to agents administered more than 4 weeks earlier (alopecia and fatigue excluded); clinical significance to be determined by investigator
- Patients may not be receiving any other investigational agents
- No prior treatment with an anti-VEGF agent allowed
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
- Patients with QTc prolongation (defined as a QTc interval greater than 500 msec) or other significant electrocardiogram (ECG) abnormalities (per investigator discretion) are excluded
- Patients with poorly controlled hypertension (systolic blood pressure of 140 mm Hg or higher or diastolic blood pressure of 90 mm Hg or higher) are ineligible
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- Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded
- Patients with any of the following conditions are excluded:
- Serious or nonhealing wound, ulcer, or bone fracture
- Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within the past 28 days
- Cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
- History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
- History of pulmonary embolism within the past 12 months
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible; patients with a history of hypothyroidism are eligible provided they are currently euthyroid
- Patients with known brain metastases
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements are ineligible
- Pregnant or breastfeeding
- No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin; Concurrent doses =< 2 mg/day allowed for prophylaxis of thrombosis, Concurrent low molecular weight heparin allowed provided prothrombin time (PT) international normalized ratio ( INR) =< 1.5
- No concurrent agents with proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide acetate)
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Pharmacodynamic Study of Sunitinib Malate in Patients With Renal Cell Cancer and Other Advanced Solid Malignancies
This phase I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the pharmacodynamic change using functional imaging (3'-deoxy-3'-[18F] fluorothymidine [FLT]-positron emission tomography [PET]/computed tomography [CT] scans) in patients with unresectable or metastatic clear cell renal cell carcinoma or other advanced solid malignancies treated with two different schedules of sunitinib malate.
II. Evaluate the objective response in patients treated with this drug.
SECONDARY OBJECTIVES:
- Measure the change in plasma vascular endothelial growth factor (VEGF) levels and plasma hypoxia-inducible factor (HIF)1-alpha levels as a potential mechanism for vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) failure and rapid tumor growth following VEGFR TKI withdrawal in these patients.
II. Correlate pharmacokinetics of this drug with response, unexpected toxicity, VEGF levels, HIF1-alpha levels, and FLT-PET/CT scan changes.
OUTLINE: Patients are assigned to 1 of 2 different treatment schedules of sunitinib malate.
SCHEDULE A: Patients receive sunitinib malate orally (PO) once daily (QD) in weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
SCHEDULE B: Patients receive sunitinib malate PO QD in weeks 1, 2, 4, and 5. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
- Conditions
- Adult Solid Neoplasm, Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
- Being tested
- Computed Tomography, Fluorothymidine F-18, Laboratory Biomarker Analysis, Pharmacological Study, Positron Emission Tomography
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyOther
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Correlative studies
Fluorothymidine F-18Other
Also called 18F-FLT, 3'-deoxy-3'-(18F) fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F 18
Correlative studies
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Positron Emission TomographyOther
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan
Correlative studies
Sunitinib MalateDrug
Also called SU011248, SU11248, sunitinib, Sutent
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Schedule A | Experimental | Patients receive sunitinib malate PO QD in weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Computed Tomography; Other: Fluorothymidine F-18; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Positron Emission Tomography; Drug: Sunitinib Malate |
| Schedule B | Experimental | Patients receive sunitinib malate PO QD in weeks 1, 2, 4, and 5. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Computed Tomography; Other: Fluorothymidine F-18; Other: Pharmacological Study; Other: Positron Emission Tomography; Drug: Sunitinib Malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response
Measured: Up to 3 years
Plasma VEGF and HIF1-alpha levels
Measured: Up to 3 years
Standard uptake value as measured by 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET/CT scans
Measured: Up to 3 years
Secondary outcomes (1)
Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, and CL)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study start22 May 2007
- Primary completion14 May 2014
- Study completion14 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Glenn Liu, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499135
- Sponsor's protocol ID
- NCI-2009-00245
- Other IDs
- NCI-2009-00245, CDR0000552705, H-2007-0039, CO06902, CO 06902, 7898, P30CA014520, U01CA062491
- Status last verified
- Oct 2017
- First submitted
- 10 Jul 2007
- Last updated
- 10 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Study of Sunitinib Malate in Patients With Renal Cell Cancer and Other Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00499135
- Acronym / sponsor ID
- NCI-2009-00245
- Conditions
- Adult Solid Neoplasm, Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 May 2007 (actual)
- Primary completion
- 14 May 2014 (actual)
- Study completion
- 14 May 2014 (actual)
- First posted
- 11 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.
This phase I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Determine the pharmacodynamic change using functional imaging (3'-deoxy-3'-[18F] fluorothymidine [FLT]-positron emission tomography [PET]/computed tomography [CT] scans) in patients with unresectable or metastatic clear cell renal cell carcinoma or other advanced solid malignancies treated with two different schedules of sunitinib malate.
II. Evaluate the objective response in patients treated with this drug.
SECONDARY OBJECTIVES:
- Measure the change in plasma vascular endothelial growth factor (VEGF) levels and plasma hypoxia-inducible factor (HIF)1-alpha levels as a potential mechanism for vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) failure and rapid tumor growth following VEGFR TKI withdrawal in these patients.
II. Correlate pharmacokinetics of this drug with response, unexpected toxicity, VEGF levels, HIF1-alpha levels, and FLT-PET/CT scan changes.
OUTLINE: Patients are assigned to 1 of 2 different treatment schedules of sunitinib malate.
SCHEDULE A: Patients receive sunitinib malate orally (PO) once daily (QD) in weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
SCHEDULE B: Patients receive sunitinib malate PO QD in weeks 1, 2, 4, and 5. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schedule A | Experimental | Other: Computed Tomography, Other: Fluorothymidine F-18, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: Positron Emission Tomography, Drug: Sunitinib MalatePatients receive sunitinib malate PO QD in weeks 1-4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. |
| Schedule B | Experimental | Other: Computed Tomography, Other: Fluorothymidine F-18, Other: Pharmacological Study, Other: Positron Emission Tomography, Drug: Sunitinib MalatePatients receive sunitinib malate PO QD in weeks 1, 2, 4, and 5. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically or cytologically confirmed renal cell cancer; or other solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which no standard curative therapy exists
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
- Life expectancy > 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Leukocytes >= 3,000/mm^3
Key exclusion criteria (21 listed)
- Patients who have had chemotherapy, radiotherapy, experimental therapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered (to grade < 1 or baseline) from clinically significant adverse events due to agents administered more than 4 weeks earlier (alopecia and fatigue excluded); clinical significance to be determined by investigator
- Patients may not be receiving any other investigational agents
- No prior treatment with an anti-VEGF agent allowed
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
- Patients with QTc prolongation (defined as a QTc interval greater than 500 msec) or other significant electrocardiogram (ECG) abnormalities (per investigator discretion) are excluded
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyCorrelative studies | Other | Schedule A, Schedule B |
| Fluorothymidine F-18Also: 18F-FLT, 3'-deoxy-3'-(18F) fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F 18Correlative studies | Other | Schedule A, Schedule B |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Schedule A |
| Pharmacological StudyCorrelative studies | Other | Schedule A, Schedule B |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scanCorrelative studies | Other | Schedule A, Schedule B |
| Sunitinib MalateAlso: SU011248, SU11248, sunitinib, SutentGiven PO | Drug | Schedule A, Schedule B |
Primary outcome
Objective response
Time frame: Up to 3 years
Plasma VEGF and HIF1-alpha levels
Time frame: Up to 3 years
Standard uptake value as measured by 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET/CT scans
Time frame: Up to 3 years
1 secondary outcome
Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, and CL)
Time frame: Up to 3 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 10 Oct 2017.
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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.
Glenn Liu principal investigator
University of Wisconsin, Madison
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 Computed Tomography, Fluorothymidine F-18 and Laboratory Biomarker Analysis in people with Adult Solid Neoplasm and Clear Cell Renal Cell Carcinoma, run by National Cancer Institute (NCI) 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 16 inclusion and 21 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 10 Oct 2017. 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?
Objective response (time frame: Up to 3 years). The study lists 3 primary outcomes in all. 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 10 Oct 2017.