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Monoclonal Antibodies
BI 765883 Alone or With Chemotherapy for Pancreatic Cancer
Phase 1
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
3. Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
4. Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 350 days (25 treatment cycles)
Awards & highlights
No Placebo-Only Group
Summary
"This trial is for adults with advanced pancreatic cancer who have not had success with previous treatments. The study aims to determine the highest safe dose of BI 765883 for these patients when taken alone or with
Who is the study for?
Adults with advanced pancreatic cancer who have not had success with previous treatments or for whom no treatment exists. They must be able to provide informed consent, have a life expectancy of at least 3 months, and agree to use effective birth control. A confirmed diagnosis of Pancreatic ductal adenocarcinoma (PDAC) is required, along with an ECOG performance status ≤1.
What is being tested?
The trial is testing the highest tolerable dose of BI 765883 alone or combined with chemotherapy in treating advanced pancreatic cancer. It's the first time BI 765883 is given to humans, aiming to check its effectiveness against this type of cancer.
What are the potential side effects?
Since BI 765883 is being tested for the first time in humans, specific side effects are unknown but may include typical reactions related to chemotherapy such as nausea, fatigue, hair loss, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using or willing to use effective birth control.
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My cancer is confirmed as pancreatic ductal adenocarcinoma.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 350 days (25 treatment cycles)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 350 days (25 treatment cycles)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Confirmed objective response (OR)
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Secondary study objectives
Area under the serum concentration time curve of the analyte (AUC0-t)
Duration of response (DOR)
Frequency and severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: BI 765883 escalation armExperimental Treatment1 Intervention
phase Ia
Group II: BI 765883 + gemcitabine + nab-paclitaxel expansion armExperimental Treatment3 Interventions
phase Ib
Group III: BI 765883 + gemcitabine + nab-paclitaxel escalation armExperimental Treatment3 Interventions
phase Ia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gemcitabine
2013
Completed Phase 3
~4260
nab-paclitaxel
2008
Completed Phase 4
~1420
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,897,226 Total Patients Enrolled