Clinical trial NCT02729194 (early phase 1, status: completed)
Conditions: carcinoma, renal cell
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: pazopanib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Adult (>18 years of age) with unresectable locally advanced or metastatic renal cell
             carcinoma with a clear cell component.

          -  Subjects must have measurable disease per RECIST 1.1 criteria.

          -  Subjects must not have had prior pazopanib therapy.

          -  Subjects must have an ECOG (Eastern Cooperative Oncology Group scoring system used to
             quantify general well-being and activities of daily life; scores range from 0 to 5
             where 0 represents perfect health and 5 represents death.) performance status of less
             than or equal to 2.

          -  Up to 3 lines of prior VEGF (vascular endothelial growth factor) or VEGFR (vascular
             endothelial growth factor receptor) targeted therapy are permitted. Any prior therapy
             should have been completed ≥ 2 weeks prior to start of study therapy.

          -  Subjects may have received any number of the following therapies: cytokine therapy
             (e.g. high dose interleukin-2) or checkpoint inhibitor therapy (e.g. anti-PD1/PDL1,
             anti-CTLA4) or mTOR inhibitor therapy (e.g. everolimus, temsirolimus).

          -  Adequate organ and marrow function (Absolute neutrophil count > 1000/mm3, platelets >
             100,000/mm3, aspartate aminotransferase/ alanine aminotransferase/ total bilirubin <
             1.5 X ULN (upper limit of normal). Patients with Gilbert's disease are exempt.

          -  Subject must be willing and able to take pazopanib with a low-fat meal every day as
             specified in the protocol.

          -  Subjects must be willing and able to come off any PPI(proton pump inhibitor)/other
             strong CYP3A4 inhibitors or inducers/simvastatin.

          -  Ability to understand and the willingness to sign a written informed consent.

          -  All subjects, including those who are surgically sterilized, must be willing to use an
             effective method of contraception.

        Exclusion Criteria:

          -  Any concurrent health condition that in the view of the treating physician would pose
             excessive risk to the patient if enrolled in the study.

          -  Subjects with a history of hemoptysis, cerebral hemorrhage, clinically significant GI
             hemorrhage, myocardial infarction within the past 6 months.

          -  Patients at significant risk for GI (gastrointestinal) perforation or fistula.

          -  Pregnant or nursing mothers.

          -  Untreated CNS (central nervous system) metastasis. If treated CNS metastasis/es,
             treatment of CNS disease (surgery or radiation) must have been completed at least 30
             days prior to registration. Patients could still be on steroids.

          -  Subjects with known history of Cirrhosis, HIV, Hepatitis B or C.

          -  Averaged QTc baseline in 3 ECGs (electrocardiograms) at least 5 minutes apart of ≥450
             ms.

          -  Congestive Heart Failure (NYHA Class III/IV) or LVEF (left ventricular ejection
             fraction) <50% at baseline.

          -  Uncontrolled hypertension (HTN) despite medical management (blood pressure (BP) ≥
             160/100.