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BI 905711 + Chemotherapy 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 13 months.
Awards & highlights
Study Summary
This trial is for adults with advanced colorectal or pancreatic cancer. The first part is to find the highest tolerable dose of BI 905711, and the second part is to see if BI 905711 makes tumours shrink. BI 905711 is given every 2 weeks as an infusion, and participants can stay in the study for as long as the treatment is effective and tolerable.
Eligible Conditions
- Metastatic Gastrointestinal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being equal or above 33% during the MTD evaluation period
Phase 1a: Number of patients with DLTs in the MTD evaluation period
Phase 1b: Confirmed objective response (OR) as assessed by the investigator
+1 moreSecondary outcome measures
Phase 1a: AUC0-t2: Area under the concentration time-curve in plasma of BI 905711 after multiple cycles
Phase 1a: AUC0-t2: Area under the concentration-time curve in plasma of BI 905711 during the first cycle
Phase 1a: Cmax: Maximum measured plasma concentration of BI 905711 after multiple cycles
+9 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 1b: FOLFIRI + BevacizumabExperimental Treatment2 Interventions
Phase 1b: Dose Expansion: Randomized cohort in 2nd line colorectal adenocarcinoma (CRC); Arm B.
Group II: Phase 1b: BI 905711 + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Phase 1b: Dose Expansion: Randomized cohort in 2nd line colorectal adenocarcinoma (CRC); Arm A.
Group III: Phase 1b: BI 905711 + FOLFIRIExperimental Treatment2 Interventions
Phase 1b: Dose Expansion: Single arm cohort in 2nd line Pancreatic Ductal Adenocarcinoma (PDAC)
Group IV: Phase 1a: BI 905711 + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Phase 1a: Dose escalation in colorectal adenocarcinoma (CRC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 905711
2020
Completed Phase 1
~130
FOLFIRI
2005
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,515 Previous Clinical Trials
11,347,275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken any non-experimental drugs, like bevacizumab, ramucirumab, aflibercept, cetuximab, or panitumumab, within the past 14 days.You have not taken any experimental drugs or immune checkpoint inhibitors in the past 28 days.You have a long-term condition called chronic pancreatitis.You have a severe gastrointestinal condition diagnosed by a doctor, such as an autoimmune disease affecting the GI tract or unexplained persistent diarrhea with a severity grade of 2 or higher.
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