The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Participants will receive GDC-1261 as per the schedule described in the protocol.
Honor Health Research Institute
Scottsdale, Arizona, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGSt Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 24 months
Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)
Time frame: From Day 1-28 of Cycle 1 (1 Cycle = 28 days)
Plasma Concentration of GDC-1261
Time frame: Up to approximately 24 months
Plasma Concentration of GDC-1261 Either in Fasted or Fed State
Time frame: Up to approximately 24 months
Prostate-Specific Antigen-30% (PSA30) Response Rate
Time frame: Up to approximately 24 months
PSA50 Response Rate
Time frame: Up to approximately 24 months
PSA90 Response Rate
Time frame: Up to approximately 24 months
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Recommended Dose of GDC-1261
Time frame: Up to approximately 24 months
Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
CONTACT
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CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Austin Hospital
Heidelberg, Victoria, Australia
RECRUITINGThe Royal Marsden in Sutton, Surrey - Downs Rd
Sutton, Surrey, United Kingdom
RECRUITING