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Crizotinib for Cancer with ROS1 Genetic Changes
Study Summary
This trial is testing if crizotinib can shrink or stop the growth of cancer that has a genetic change called ROS1 translocation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 207 Patients • NCT01639001Trial Design
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Who is running the clinical trial?
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- My recent ECG showed no significant heart issues.I am not using any strong medications or foods that affect drug metabolism.I have never been treated with ROS1 inhibitors.My NSCLC does not have ROS1 rearrangements.I have never had interstitial lung disease or pneumonitis.My cancer has a specific genetic change in the ROS1 gene.
- Group 1: Treatment (crizotinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any openings to become a participant in this experiment?
"Unfortunately, this clinical trial is not actively recruiting participants. The study was initially posted on August 12th 2015 and the last update occurred on August 30th 2022. Nevertheless, there are currently 4739 other studies searching for volunteers at this time."
How many participants are currently involved in this research endeavor?
"This research is no longer looking for enrollees. The investigation was initially posted on August 12, 2015 and the last update happened on 8/30/2022. If you look into other studies, there are 4669 trials searching for patients with refractory plasma cell myeloma and 70 clinical investigations actively enrolling people in Crizotinib therapy."
What objective is this experiment aiming to achieve?
"This study's primary aim is to evaluate the Objective Response Rate (ORR) through assessing Tumours at baseline, every 2 cycles for 26 rounds of analysis and every 3 cycles until disease progression or up to 3 years post registration. Secondary outcomes include 6-month Progression-free Survival (PFS) Rate estimated with Kaplan-Meier method, Overall survival (OS), evaluated specifically for each drug using the same statistical approach and PFS assessed via a similar technique."
Has Crizotinib received regulatory authorization from the Food and Drug Administration?
"Crizotinib's safety has been partially established by clinical data, thus it received a rating of 2. This Phase 2 trial does not yet have any information confirming efficacy."
What health conditions does Crizotinib typically address?
"Crizotinib is commonly prescribed to alleviate the effects of renal dysfunction, amino acid supplementation and a variety of other medical issues."
Is this pioneering clinical trial breaking new ground?
"To date, 70 clinical trials for Crizotinib have been launched in 1216 cities from 37 countries. This drug first appeared in a 2007 Baxter Healthcare Corporation-sponsored study that included 4640 participants and concluded with Phase 4 approval. Over the last 14 years, 79 studies involving this medication have been conducted."
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