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BI 1701963 + Trametinib for Advanced Cancer
Study Summary
This trial is testing a new drug to see if it can shrink tumors in adults with advanced cancer that didn't respond to previous chemotherapy.
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.Trial Design
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Who is running the clinical trial?
Media Library
- I do not have active or symptomatic brain metastases.I have signed and understand the consent form for this trial.I am a woman who can have children and have a negative pregnancy test.I have received both chemotherapy and immunotherapy.I haven't had cancer chemotherapy in the last 3 weeks.I have been treated with drugs targeting RAS, MAPK, or SOS1.I have a lung condition known as interstitial lung disease.I have signed and understand the consent form for this trial.My organs are working well.I have not had major surgery in the last 4 weeks.This applies to all parts of the screening process.I have had a blocked vein in my eye or a layer of my retina has detached.My cancer has worsened despite treatment, or there are no standard treatments for my cancer type and stage.My cancer has a KRAS mutation.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I do not have severe heart problems or a recent heart attack.There are additional criteria that must be met to be included in the study.My cancer has spread to the lining of my brain and spinal cord.I am 18 years old or older.I don't have uncontrolled stomach or bowel issues affecting drug absorption.I have a genetic condition that affects my heart's rhythm.My lung cancer is mainly adenocarcinoma.My lung cancer is at an advanced stage (IIIb or IV).I am fully active or restricted in physically strenuous activity but can do light work.My lung cancer is mainly adenocarcinoma.I currently have an active infection.
- Group 1: BI 1701963 + Trametinib
- Group 2: BI 1701963 monotherapy
- 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
Has research been conducted on BI 1701963 previously?
"BI 1701963 was first tested at the University of Chicago Medical Center in 2012, and since then there have been 69 trials that were concluded. Nowadays, 92 separate studies are taking place, many of which being conducted out of Houston Texas."
Are there vacancies available for persons interested in participating in this research study?
"This trial has ended its recruitment of patients. It was initially announced on October 28th 2019 and updated lastly on November 14th 2022. For other studies, there are presently 2380 trials recruiting participants with solid tumors and kras mutation; sos1 as well as 92 studies seeking enrolment for BI 1701963."
How many locations are participating in this experiment?
"Currently, The University of Texas MD Anderson Cancer Centre in Houston, Sarah Cannon Research Institute in Nashville, and Dana-Farber Cancer Institute in Boston are among the 4 clinical trial sites actively recruiting patients for this study."
How many participants are taking part in this experiment?
"This study has closed its recruitment period; the initial posting was on October 28th 2019 and it last updated November 14th 2022. If you are in search of other trials, there exist 2380 medical studies actively recruiting patients with solid tumors carrying KRAS mutation SOS1 mutations, as well as 92 clinical trials for BI 1701963 also seeking participants."
Has the FDA acquiesced to BI 1701963's clinical use?
"Since BI 1701963 is still in its early stages of testing, the safety and efficacy profile has been given a score of 1."
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