Trial Title:
A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy
NCT ID:
NCT06528093
Condition:
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI 765883
Description:
BI 765883
Arm group label:
BI 765883 + gemcitabine + nab-paclitaxel escalation arm
Arm group label:
BI 765883 + gemcitabine + nab-paclitaxel expansion arm
Arm group label:
BI 765883 escalation arm
Intervention type:
Drug
Intervention name:
gemcitabine
Description:
gemcitabine
Arm group label:
BI 765883 + gemcitabine + nab-paclitaxel escalation arm
Arm group label:
BI 765883 + gemcitabine + nab-paclitaxel expansion arm
Intervention type:
Drug
Intervention name:
nab-paclitaxel
Description:
nab-paclitaxel
Arm group label:
BI 765883 + gemcitabine + nab-paclitaxel escalation arm
Arm group label:
BI 765883 + gemcitabine + nab-paclitaxel expansion arm
Summary:
This study is open to adults with advanced pancreatic cancer for whom previous treatment
was not successful or no treatment exists.
The purpose of this study is to find the highest dose of BI 765883 that people with
advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy.
Another purpose is to check whether BI 765883 helps people with advanced pancreatic
cancer. In this study, BI 765883 is given to humans for the first time.
Participants receive either BI 765883 alone or BI 765883 in combination with
chemotherapy. Participants can stay in the study as long as they benefit from treatment
and can tolerate it. At study visits, doctors collect information on any health problems
of the participants and check the severity of participants' cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial
2. Of legal adult age (according to local legislation) at screening
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)
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
6. Life expectancy ≥3 months in the opinion of the investigator
7. Archived tumor tissue from a tissue core biopsy (e.g. paraffin-embedded
formalin-fixed tissue blocks), OR fresh tumor tissue available for retrospective
biomarker analysis; in both cases, a minimum of at least two core needle biopsies
(18 gauge or greater) is required. Only non-significant risk procedures per the
investigator's judgment will be used to obtain any biopsies specified in this study
in cases where a fresh tumor biopsy is required.
8. Patients with at least 1 target lesion that can be accurately measured per RECIST
version 1.1 Further inclusion criteria apply.
Exclusion Criteria:
1. Previous exposure to trial drug (BI 765883)
2. Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts)
3. Known hypersensitivity to the study medications or their excipients (including
gemcitabine and nab-paclitaxel)
4. Any contraindications to gemcitabine or nab-paclitaxel according to the current
approved local labels (combination therapy)
5. Currently enrolled in another investigational device or drug trial, or less than 28
days since ending another investigational device or drug trial(s) or receiving other
investigational treatment(s)
6. Any serious concomitant disease or medical condition affecting compliance with trial
requirements or which are considered relevant for the evaluation of the efficacy or
safety of the trial drug, such as neurologic, psychiatric, infectious disease,
active ulcers (gastrointestinal tract, skin), inflammatory bowel disease or bowel
infection, or laboratory abnormality that may increase the risk associated with
trial participation or trial drug administration, and in the judgment of the
Investigator, would make the patient inappropriate for entry into the trial.
7. Prior radiotherapy or systemic therapy within 14 days prior to treatment start
8. History or presence of cardiovascular abnormalities such as uncontrolled
hypertension, congestive heart failure NYHA classification of ≥III or IV, unstable
angina or poorly controlled arrhythmia which are considered as clinically relevant
by the Investigator Further exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba, Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Start date:
August 23, 2024
Completion date:
October 13, 2027
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06528093
http://www.mystudywindow.com
