Advanced Prostate Cancer, Metastatic Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGGDC-1261
Participants will receive GDC-1261 as per the schedule described in the protocol.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 24 months |
| Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs) | From Day 1-28 of Cycle 1 (1 Cycle = 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Concentration of GDC-1261 | Up to approximately 24 months |
| Plasma Concentration of GDC-1261 Either in Fasted or Fed State | Up to approximately 24 months |
| Prostate-Specific Antigen-30% (PSA30) Response Rate | Up to approximately 24 months |
| PSA50 Response Rate | Up to approximately 24 months |
| PSA90 Response Rate | Up to approximately 24 months |
| Objective Response Rate (ORR) | Up to approximately 24 months |
| Recommended Dose of GDC-1261 | Up to approximately 24 months |
Countries
Australia, United Kingdom, United States
Contacts
CONTACTReference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed