Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal… (NCT03541902) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma
United States32 participantsStarted 2018-05-15
Plain-language summary
The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer.
This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC.
The study doctor can explain how the study drugs are designed to work.
Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The subject has a histologic or cytologic diagnosis of a variant histology renal cell carcinoma including papillary, chromophobe, Xp.11 translocation, undifferentiated, or unclassified which is treatment naïve or has previously been treated with one systemic treatment line not containing any vascular endothelial growth factor antibody or vascular endothelial growth factor receptor tyrosine kinase inhibitors. The patient may have received treatment with immune checkpoint therapy including nivolumab as a single agent or nivolumab plus ipilimumab in combination. Previous treatment with mammalian target of rapamycin agents such as temsirolimus or everolimus is acceptable.
✓. Measurable disease per RECIST v1.1 as determined by the investigator.
✓. The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib or sunitinib.
✓. The subject is \>/=18 years old on the day of consent;
✓. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of \</=2.
✓. Recovery to baseline or \</= Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy;
✓. The subject has organ and marrow function and laboratory values as follows within 4 days before the first dose of cabozantinib or sunitinib: a.The ANC \>/= 1500/mm\^3 without colony stimulating factor support; b.White blood cell count \>/= 2500/mm\^3 (\>/= 2.5 GI/L). c.Platelets \>/=100,000/mm\^3; d.Hemoglobin \>/= 9 g/dL; e. Bilirubin \</= 1.5 x the ULN. For subjects with known Gilbert's disease, bilirubin \</= 3.0 mg/dL; f.Serum albumin \>/= 2.8 g/dl g.Serum creatinine \</= 2.0 X ULN or calculated creatinine clearance \>/= 30 mL/min (\>/= 0.5 mL/sec) using the Cockcroft-Gault equation: Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72) Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85 h.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) \</= 3 X upper limit of normal (ULN). ALP \</= 5 X ULN with documented bone metastases. i.Urine protein/creatinine ratio (UPCR) \</= 1 mg/mg (\</= 113.2 mg/mmol);
What they're measuring
1
Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria
Timeframe: From randomization up to the time of disease progression or death up to two years
✓. The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document;
Exclusion criteria
✕. The subject has a variant histology that includes renal medullary carcinoma or collecting duct renal cell carcinoma. Any clear cell component in the tumor will lead to exclusion.
✕. The subject has received any previous anti-angiogenic agent. Prior treatment with cabozantinib.
✕. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible;
✕. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment;
✕. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment;
✕. Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following: o Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted. o Low-dose low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
✕. The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) tes\>/=1.3 X the laboratory ULN within 7 days before the first dose of study treatment.
✕. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: a.Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. b.Uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic or \> 100 mm Hg diastolic despite optimal antihypertensive treatment. c.Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose.