Locally advanced or metastatic pancreatic adenocarcinoma MedDRA version: 17.1 Level: LLT Classification code 10033600 Term: Pancreatic adenocarcinoma non-resectable System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 100000004864
Conditions
Interventions
Product Code: Atu027
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: ATU-RNA 027/23H
Other descriptive name: ATU-RNA 027/23H
Sponsors
Silence Therapeutics GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Lead-in safety period: 1. Subjects between the age of 18 and 84 years 2. Histologically or cytologically confirmed advanced or refractory cholangiocellular carcinoma, biliary tract cancer, non-small-cell lung carcinoma, duodenal cancer, soft tissue sarcoma, ovarian carcinoma, or another non-pancreatic cancer disease indicated for gemcitabine treatment as determined by the investigator 3. Subjects who have previously received chemotherapy and standard curative or palliative care is not available, not effective, or unlikely to be effective 4.No option for surgical resection or radiation in curative intent 5.Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 – 2 6.Life expectancy of at least 3 months 7.No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung 8.Alanine aminotransferase (ALT) =3.0 x upper limit of normal (ULN; =5 x ULN for subjects with liver metastases) 9.Aspartate aminotransferase (AST) =3.0 x ULN (=5 x ULN for subjects with liver involvement with cancer) 10.Total bilirubin =2.0 x ULN (liver metastasis =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: Lead-in safety period: 1. History of cardiac disease; congestive heart failure >New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy 2. Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) =7% 3. Poorly controlled hypertension, defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management 4. Poorly controlled seizure disorder 5. Subjects undergoing renal dialysis 6. Known hypersensitivity to the study drugs or active substances or excipients of the preparations 7. Pregnant or breast feeding 8. Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject’s record) 9. Previous participation in this study 10. Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study. 11. Subject is a relative of, or staff directly reporting to the investigator. 12. Subject is an employee of the sponsor. 13. Subject is committed under official or judicial order. 14. Any other reason that the investigator considers makes the subject unsuitable to participate Main part: 1. History of cardiac disease; congestive heart failure >New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy 2. Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) =8% 3. Poorly controlled hypertension, defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management 4. Poorly controlled seizure disorder 5. Subjects undergoing renal dialysis 6. Anticancer chemotherapy or immunotherapy during the study or before first study treatment. Subjects with recurrent disease after adjuvant treatment not progression-free for at least 6 months. 7. Radiotherapy to target lesions during study or before study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate the safety and pharmacokinetics of Atu027 when used in combination with gemcitabine in subjects with locally advanced or metastatic pancreatic adenocarcinoma. ;Secondary Objective: The secondary objective of this study will be to evaluate the efficacy of Atu027 when used in combination with gemcitabine.;Primary end point(s): No formal primary or secondary endpoints will be defined. However, safety and PK variables will be of primary interest. Safety (Physical examination, Vital signs, Body weight,12-lead electrocardiogram (ECG; including QTc) Clinical laboratory parameters including hematology, clinical chemistry, and urinalysis) Pharmacokinetics ;Timepoint(s) of evaluation of this end point: Safety and Pharmacokinetics assessments will be done throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary variables: Objective response rate: response will be assessed by RECIST Version 1.1, Progression-free survival, Overall survival, ECOG performance score, Biomarker response), Tumor marker response, Quality of life;Timepoint(s) of evaluation of this end point: Response related outcome assessments will be done throughout the study | — |
Countries
Germany
Contacts
Public ContactDirector Project Management
Silence Therapeutics GmbH
Outcome results
None listed