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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation + Expansion | Experimental | Participants will receive GDC-1261 as per the schedule described in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-1261 | Drug | Participants will receive GDC-1261 as per the schedule described in the protocol. |
|
| Measure | Description | 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) |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Recruiting | Scottsdale | Arizona | 85258-4566 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| 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 |
| Sarah Cannon Research Institute |
| Recruiting |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| St Vincent's Hospital Sydney | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Austin Hospital | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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