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BI 905711 for Gastrointestinal Cancer
Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 1 and up to day 19
Awards & highlights
Study Summary
This trial is exploring the safety and efficacy of BI 905711 in order to determine a recommended dose for further study.
Eligible Conditions
- Gastrointestinal Tumors
- Pancreatic Cancer
- Bile Duct Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 1 and up to day 19
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 1 and up to day 19
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase Ia - Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true DLT rate being equal or above 33% during the MTD evaluation period
Phase Ia - Number of patients with DLTs in the MTD evaluation period
Phase Ib - Objective response based on RECIST 1.1 criteria
+1 moreSecondary outcome measures
Phase Ia - AUC0-t2: area under the concentration-time curve of BI 905711 in plasma
Phase Ia - Cmax: maximum measured concentration of BI 905711 in plasma
Phase Ia - Objective response based on RECIST 1.1 criteria in patients with measurable disease
+6 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Phase Ib: BI 905711 - dose level 4Experimental Treatment1 Intervention
Group II: Phase Ib: BI 905711 - dose level 3Experimental Treatment1 Intervention
Group III: Phase Ib: BI 905711 - dose level 2Experimental Treatment1 Intervention
Group IV: Phase Ib: BI 905711 - dose level 1Experimental Treatment1 Intervention
Group V: Phase Ia: BI 905711 - dose escalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 905711
2020
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,464 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least one specific area of the body that can be accurately measured according to a certain set of rules.You have tried all the standard treatments for your disease, but they haven't worked.You are able to perform everyday activities without help.You have a medical condition in your stomach, intestines, liver, or pancreas that could make it hard to tell if the study drug is safe for you, or that could make the drug more likely to cause harm.You have lab results showing infection with hepatitis virus.You have another type of cancer that is currently being treated.You have uncontrolled or symptoms-causing brain or subdural metastases.You have any of the listed heart-related conditions.Your liver, kidney, and bone marrow are working well based on specific tests.You are expected to live for at least 3 more months.You have had HIV in the past.You have been diagnosed with advanced, unresectable, or metastatic gastrointestinal cancers of specific types.Any side effects from previous cancer treatments must be back to normal or only mild.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ia: BI 905711 - dose escalation
- Group 2: Phase Ib: BI 905711 - dose level 1
- Group 3: Phase Ib: BI 905711 - dose level 2
- Group 4: Phase Ib: BI 905711 - dose level 3
- Group 5: Phase Ib: BI 905711 - dose level 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to join the study at this time?
"Affirmative. Clinicaltrials.gov verifies that the trial is currently recruiting, having initially been posted on March 11th 2020 and last modified November 28th 2022. The research requires 140 volunteers at a total of 4 sites."
Answered by AI
To what extent is this medical study involving participants?
"This experiment necessitates the recruitment of 140 suitable patients, and is overseen by Boehringer Ingelheim. Clinical trials will take place in Yale Cancer Center, New Haven Connecticut and START South Texas Accelerated Research Therapeutics LLC based out of San Antonio, Texas."
Answered by AI
Are there any potential risks associated with BI 905711 for patients?
"Due to its Phase 1 status, BI 905711's safety assessment is rated at a 1 as there is only minimal data available that confirms its efficacy and security."
Answered by AI
What is the current count of medical sites participating in this trial?
"Patients may participate in the clinical trial at Yale Cancer Center in New Haven, START South Texas Accelerated Research Therapeutics LLC in San Antonio, The University of Texas MD Anderson Cancer Center in Houston, and 4 other medical sites."
Answered by AI
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