XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer
PRO-XL: A Phase II Study of XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer After Progression on Lutetium-177 (177Lu)-PSMA-617
Sponsor: University of Utah + Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Proportion of participants with non-progressive disease after 16 weeks of treatment with XL092 as assessed by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1
Time frame: 16 weeks
Secondary Endpoints
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Eligibility Criteria
Inclusion Criteria: * Participant aged ≥ 18 years * Disease criteria: * Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology * Radiographic evidence of metatstatic disease * Progression on or after prior treatment with 177Lu-PSMA-617 as determined by clinical investigator * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: --Absolute neutrophil count ≥ 1500/mm3 . * Platelet count ≥ 100,000/mm3 . * Hemoglobin ≥ 9 g/dL . * Total Bilirubin ≤ 1.5x institutional ULN. For subject's with Gilbert's disease, ≤ 3 x ULN. * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN. For subjects with CRPC and bone metastasis ALP ≤ 10 x ULN if predominantly bone-specific ALP. * International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 upper limit of normal (ULN) * Seru…
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