Spots Global Cancer Trial Database for Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
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Trial Identification
Brief Title: Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
Official Title: Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
Study ID: NCT06085729
Conditions
Study Description
Brief Summary: To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.
Detailed Description: Primary Objective: To select an optimal dose of ADI-PEG 20 to combine with carboplatin+cabazitaxel Secondary Objectives: To determine the effects of ADI-PEG 20+carboplatin+cabazitaxel on 1. Serum levels of arginine, citrulline and circulating anti-ADI-PEG 20 antibodies 2. Intratumoral levels of arginine by ion chromatography/mass spectrometry 3. Expression of ASS1 by immunohistochemistry 4. Expression of genes involved in arginine metabolism and downstream pathways 5. Immune checkpoint expression and immune-cell populations in the AVPC tumor microenvironment 6. Safety and tolerability 7. Overall response 8. Progression-free survival 9. Overall survival
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Ana Aparicio, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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