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NCT03194893 · ClinicalTrials.gov registry record · Phase 3
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
A Phase 3 study of Neoplasms, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT03194893: Active Phase 3 study of Neoplasms, sponsored by Hoffmann-La Roche.
NCT03194893 is a Phase 3 study of Neoplasms that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 200 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03194893, a Phase 3 study of Neoplasms, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.
Primary Outcome
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-pati
Conditions Studied
Interventions
- DRUG Alectinib
- DRUG Crizotinib
Study Locations (20)
Other
- Centre Francois Baclesse - Caen
- Centre Georges François Leclerc - Dijon
- Centre Oscar Lambret - Lille
- Centre Leon Berard - Lyon
- Groupe Hospitalier Sud - Hôpital Haut Lévêque - Pessac
- Hopital Pontchaillou - CHU de Rennes - Rennes
- CHU de Toulouse - Hôpital Larrey - Toulouse
- Hopital Robert Schuman - Vantoux
- Queen Mary Hospital - Hong Kong
- Queen Elizabeth Hospital Department of Clinical Oncology - Kowloon
- Uniwersyteckie Centrum Kliniczne - Gda?sk
Moscow Oblast
- FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow
- University ?linic of headaches - Moscow
- City Clinical Oncology Hospital - Moscow
California
- Chao Family Comprehensive Cancer Center - Orange
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Friuli Venezia Giulia
- Irccs Centro Di Riferimento Oncologico (CRO) - Aviano
Lazio
- Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1 - Rome
Tuscany
- Azienda Ospedaliero-Universitaria Careggi - Florence
Umbria
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia - Perugia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2026-05-30 |
| Phase | Phase 3 |
What the registry record for NCT03194893 still lists
NCT03194893 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Alectinib is the first listed.
NCT03194893 names 20 study sites across 8 states, led by Other, Moscow Oblast, California.
Frequently Asked Questions
What is clinical trial NCT03194893 about?
NCT03194893 is a clinical study titled "A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer". The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in ...
What is the current status of trial NCT03194893?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2017-07-05. Estimated completion is 2026-05-30.
What conditions does trial NCT03194893 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT03194893?
The interventions under investigation include: Alectinib (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT03194893?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03194893 being conducted?
This trial has 20 study locations across California, Massachusetts, Friuli Venezia Giulia, Lazio, Tuscany. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03194893's enrollment target sits among peer trials
200 49th of 158 higher than 109 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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