NCT00499135

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2014

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

7 years

First QC Date

July 10, 2007

Last Update Submit

October 9, 2017

Conditions

Adult Solid NeoplasmClear Cell Renal Cell CarcinomaRecurrent Renal Cell CarcinomaStage III Renal Cell CancerStage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (3)

  • Objective response

    Up to 3 years

  • Plasma VEGF and HIF1-alpha levels

    Up to 3 years

  • Standard uptake value as measured by 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET/CT scans

    Up to 3 years

Secondary Outcomes (1)

  • Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, and CL)

    Up to 3 years

Study Arms (2)

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.

Other: Computed TomographyOther: Fluorothymidine F-18Other: Laboratory Biomarker AnalysisOther: Pharmacological StudyOther: Positron Emission TomographyDrug: 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.

Other: Computed TomographyOther: Fluorothymidine F-18Other: Pharmacological StudyOther: Positron Emission TomographyDrug: Sunitinib Malate

Interventions

Computed TomographyOTHER

Correlative studies

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Schedule ASchedule B
Fluorothymidine F-18OTHER

Correlative studies

Also known as: 18F-FLT, 3'-deoxy-3'-(18F) fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F 18
Schedule ASchedule B
Laboratory Biomarker AnalysisOTHER

Correlative studies

Schedule A
Pharmacological StudyOTHER

Correlative studies

Schedule ASchedule B
Positron Emission TomographyOTHER

Correlative studies

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Schedule ASchedule B
Sunitinib MalateDRUG

Given PO

Also known as: SU011248, SU11248, sunitinib, Sutent
Schedule ASchedule B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

alovudineMagnetic Resonance SpectroscopySunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Glenn Liu

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

May 22, 2007

Primary Completion

May 14, 2014

Study Completion

May 14, 2014

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

US(1)