Phase
Condition
Renal Cell Cancer
Carcinoma
Renal Cell Carcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must have a pathologically documented, definitively diagnosed, clear cell RCCthat is relapsed/refractory following at least two lines of systemic therapy (one ofwhich must be a tyrosine kinase), or the subject refuses standard therapy
Measurable disease per RECIST 1.1 criteria. Subjects with non-measurable, butevaluable disease are also eligible for Part 1 of the study.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Willing to provide tumor samples and / or slides
Hematological function, as follows:
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
Platelet count ≥ 100 x 10^9/L;
Hemoglobin > 9 g/dL
Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upperlimit of normal (IULN)
Hepatic function, as follows:
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN;
Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert'sDisease or for whom the indirect bilirubin level suggests an extrahepatic sourceof elevation);
Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsoragree that clinical data suggest extrahepatic source of elevation)
- Other inclusion criteria may apply
Exclusion
Exclusion Criteria:
Known primary central nervous system (CNS) tumors or brain metastases
History of bleeding diathesis
Myocardial infarction within 6 months of study day 1, symptomatic congestive heartfailure (New York Heart Association > class II), unstable angina, or unstable cardiacarrhythmia requiring medication, or uncontrolled hypertension in the opinion of theinvestigator
Clinically significant ECG changes which obscure the ability to assess the PR, QT, andQRS interval; congenital long QT syndrome
A baseline ECG QTcF > 470 msec
Known positive test for human immunodeficiency virus (HIV)
Known acute or chronic hepatitis B or hepatitis C infection as determined by serologictests
Other exclusion criteria may apply
Study Design
Study Description
Connect with a study center
Research Site
Villejuif, 94805
FranceSite Not Available
Research Site
Heidelberg, 69120
GermanySite Not Available
Research Site
Scottsdale, Arizona 85258
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
St Louis, Missouri 63110
United StatesSite Not Available
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