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NCT02316509 · ClinicalTrials.gov registry record · Phase 1
A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 13
- Study locations
NCT02316509: Completed Phase 1 study of Breast Cancer, sponsored by Genentech.
NCT02316509 is a Phase 1 study of Breast Cancer that has completed, run by Genentech. The registered enrollment target is 43 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316509, a Phase 1 study of Breast Cancer, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The study will be conducted in two parts: Dose escalation and Dose expansion. During dose escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation during the lead-in period. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose expansion, there will be no PK week lead-in period. All participants will be treated until disease progression, unacceptable toxicity, participant withdrawal of consent or study termination.
Conditions Studied
Interventions
- DRUG GDC-0927
Study Locations (13)
Other
- Hospital Univ Vall d'Hebron; Servicio de Oncologia - Barcelona
- MD Anderson Cancer Center Madrid - España; Servicio de Farmacia - Madrid
- Hospital Universitario Ramón y Cajal - Madrid
- Hospital General Universitario Gregorio Maranon - Madrid
- HM Sanchinarro - CIOCC - Madrid
- Hospital Clinico Universitario de Valencia - Valencia
Massachusetts
- Massachusetts General Hospital. - Boston
- Dana Farber Cancer Institute - Boston
Tennessee
- Sarah Cannon Cancer Center - Germantown
- Vanderbilt Ingram Cancer Ctr - Nashville
New York
- Memorial Sloan Kettering Cancer Center - New York
Barcelona
- ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO - L'Hospitalet de Llobregat
Guipuzcoa
- Onkologikoa - Kutxaren Institutu Onkologikoa - Donostia / San Sebastian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-03-17 |
| Est. Completion | 2020-01-10 |
| Phase | Phase 1 |
What the finished NCT02316509 record still lists
NCT02316509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which GDC-0927 is the first listed.
NCT02316509 lists 13 locations in 6 states (Other, Massachusetts, Tennessee).
Frequently Asked Questions
What is clinical trial NCT02316509 about?
NCT02316509 is a clinical study titled "A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer". This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The study will be conducted in tw...
What is the current status of trial NCT02316509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-03-17. Estimated completion is 2020-01-10.
What conditions does trial NCT02316509 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02316509?
The interventions under investigation include: GDC-0927 (DRUG).
Who is sponsoring clinical trial NCT02316509?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02316509 being conducted?
This trial has 13 study locations across Massachusetts, New York, Tennessee, Barcelona, Guipuzcoa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02316509's enrollment target sits among peer trials
43 855th of 1224 higher than 362 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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