Phase
Condition
Adenocarcinoma
Pancreatic Cancer
Pancreatic Disorders
Treatment
nab-paclitaxel
gemcitabine
BI 765883
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated written informed consent in accordance with ICH-GCP and locallegislation prior to admission to the trial
Of legal adult age (according to local legislation) at screening
Male or female patients. Women of childbearing potential (WOCBP) and men able tofather a child must be willing and able to use highly effective methods of birthcontrol per ICH M3 (R2) that result in a low failure rate of less than 1% per yearwhen used consistently and correctly.
Histologically or cytologically confirmed Pancreatic ductal adenocarcinoma (PDAC)
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Life expectancy ≥3 months in the opinion of the investigator
Archived tumor tissue from a tissue core biopsy (e.g. paraffin-embeddedformalin-fixed tissue blocks), OR fresh tumor tissue available for retrospectivebiomarker 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 theinvestigator's judgment will be used to obtain any biopsies specified in this studyin cases where a fresh tumor biopsy is required.
Patients with at least 1 target lesion that can be accurately measured per RECISTversion 1.1 Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
Previous exposure to trial drug (BI 765883)
Any prior gemcitabine and/or paclitaxel therapy (for combination therapy cohorts)
Known hypersensitivity to the study medications or their excipients (includinggemcitabine and nab-paclitaxel)
Any contraindications to gemcitabine or nab-paclitaxel according to the currentapproved local labels (combination therapy)
Currently enrolled in another investigational device or drug trial, or less than 28days since ending another investigational device or drug trial(s) or receiving otherinvestigational treatment(s)
Any serious concomitant disease or medical condition affecting compliance with trialrequirements or which are considered relevant for the evaluation of the efficacy orsafety of the trial drug, such as neurologic, psychiatric, infectious disease,active ulcers (gastrointestinal tract, skin), inflammatory bowel disease or bowelinfection, or laboratory abnormality that may increase the risk associated withtrial participation or trial drug administration, and in the judgment of theInvestigator, would make the patient inappropriate for entry into the trial.
Prior radiotherapy or systemic therapy within 14 days prior to treatment start
History or presence of cardiovascular abnormalities such as uncontrolledhypertension, congestive heart failure NYHA classification of ≥III or IV, unstableangina or poorly controlled arrhythmia which are considered as clinically relevantby the Investigator Further exclusion criteria apply.
Study Design
Connect with a study center
Cliniques Universitaires Saint-Luc
Brussels 2800866, 1200
BelgiumSite Not Available
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
UZ Leuven
Leuven 2792482, 3000
BelgiumSite Not Available
CTR Leon Berard
Lyon, 69373
FranceSite Not Available
CTR Leon Berard
Lyon 2996944, 69373
FranceSite Not Available
CTR Eugène Marquis
Rennes, 35042
FranceSite Not Available
CTR Eugène Marquis
Rennes 2983990, 35042
FranceSite Not Available
INS Gustave Roussy
Villejuif, 94805
FranceSite Not Available
INS Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
GermanySite Not Available
Universitätsklinikum Hamburg, Eppendorf
Hamburg 2911298, 20246
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg 2907911, 69120
GermanySite Not Available
Klinikum der Universität München AÖR
München, 81377
GermanySite Not Available
Klinikum der Universität München AÖR
München 2867711, 81377
GermanySite Not Available
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
JapanSite Not Available
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
JapanSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona 3128760, 08036
SpainSite Not Available
Hospital Ramón y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario Ramon Y Cajal
Madrid 3117735, 28034
SpainSite Not Available
HealthONE
Denver, Colorado 80218
United StatesSite Not Available
HealthONE
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06510
United StatesSite Not Available
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesSite Not Available
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida 34232
United StatesSite Not Available
Florida Cancer Specialists-Sarasota-61670
Sarasota 4172131, Florida 4155751 34232
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
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