A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
About this study
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.
- Condition
- Advanced Prostate Cancer, Metastatic Prostate Cancer
- Tested
- GDC-1261
- Sponsor
- Genentech, Inc.
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Advanced Prostate Cancer, Metastatic Prostate Cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of \<=1
- Life expectancy is \>= 3 months
- Histologically or cytologically confirmed prostate adenocarcinoma
- Disease progression during or following the direct prior line of therapy
- Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
- Metastatic disease
- Adequate end organ function
Exclusion 7
- Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
- Structurally unstable bone lesions suggest an impending fracture
- Untreated central nervous system (CNS) metastases or leptomeningeal disease
- Uncontrolled pain
- History of malignancy within 5 years
- Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
- Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results
Where
5 sites, 5 recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Royal Marsden in Sutton, Surrey - Downs Rd
Sutton, Surrey, United Kingdom
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
Contact
-
Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 global-roche-genentech-trials@gene.com
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Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Potential match only. Final eligibility is determined by the study team.