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NCT03695380 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
A Phase 1 study of Ovarian Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 20
- Study locations
NCT03695380: Completed Phase 1 study of Ovarian Cancer, sponsored by Hoffmann-La Roche.
NCT03695380 is a Phase 1 study of Ovarian Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 77 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03695380, a Phase 1 study of Ovarian Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2). The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2). Stage 1 will enable patient enrollment in the randomized phase of the study (Stage 2) with both regimens at the recommended dose levels from Stage 1. Stage 2 is a randomized, dose-expansion phase, evaluating clinical outcomes in patients with advanced platinum-sensitive ovarian cancer. All patients will continue to receive study treatment until disease progression (according to "Response Evaluation Criteria in Solid Tumors" (RECIST), Version 1.1, unacceptable toxicity, death, or patient or investigator decision to withdraw, whichever occurs first.
Primary Outcome
The safety profiles of Cobimetinib plus Niraparib and Cobimetinib plus Niraparib plus Atezolizumab will be evaluated in terms of number of patients reporting serious and non-serious AEs with severity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI - CTCAE v5.0)
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Niraparib
- DRUG Cobimetinib
Study Locations (20)
Other
- Hospital Universitari Vall dHebron; Oncology - Barcelona
- ICO Girona - Girona
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia - Jaén
- Clinica Universidad de Navarra Madrid; Servicio de Oncología - Madrid
- Hospital Ramon y Cajal; Servicio de Oncologia - Madrid
- Hospital Clinico San Carlos; Servicio de Oncologia - Madrid
- Hospital Clínico Universitario de Valencia; Servicio de Oncología - Valencia
Florida
- Mayo Clinic-Jacksonville - Jacksonville
- Florida Hospital Cancer Institute; Clinical Research Department - Orlando
Arizona
- University of Arizona Cancer Center, North - Tucson
California
- Moores Cancer Center at UC San Diego Health - La Jolla
Georgia
- Medical College of Georgia; Obstetrics & Gynecolog - Augusta
Missouri
- Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology - St Louis
Oklahoma
- Stephenson Cancer Center Investigational Pharmacy - Oklahoma City
Tennessee
- Tennessee Oncology; Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2023-07-12 |
| Phase | Phase 1 |
What the finished NCT03695380 record still lists
NCT03695380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT03695380 names 20 study sites across 13 states, led by Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03695380 about?
NCT03695380 is a clinical study titled "A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer". The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2). The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2). Stage 1 will enable pa...
What is the current status of trial NCT03695380?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2019-01-09. Estimated completion is 2023-07-12.
What conditions does trial NCT03695380 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT03695380?
The interventions under investigation include: Atezolizumab (DRUG), Niraparib (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT03695380?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03695380 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03695380's enrollment target sits among peer trials
77 169th of 322 higher than 154 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian 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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