Status:
COMPLETED
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)
Lead Sponsor:
Silence Therapeutics GmbH
Collaborating Sponsors:
Granzer Regulatory Consulting & Services
FGK Clinical Research GmbH
Conditions:
Carcinoma, Pancreatic Ductal
Eligibility:
All Genders
18-84 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic cancer disease by combining the new investigational medicinal product Atu027 with the standard chemotherapeutic...
Eligibility Criteria
Inclusion
- Lead-in safety period:
- Subjects between the age of 18 and 84 years
- 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
- Subjects who have previously received chemotherapy and standard curative or palliative care is not available, not effective, or unlikely to be effective
- No option for surgical resection or radiation in curative intent
- Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
- Life expectancy of at least 3 months
- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN; ≤5 x ULN for subjects with liver metastases)
- Aspartate aminotransferase (AST) ≤3.0 x ULN (≤5 x ULN for subjects with liver involvement with cancer)
- Total bilirubin ≤2.0 x ULN (liver metastasis \<5 x ULN)
- Serum creatinine ≤1.5 x ULN
- Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 10e6/L) and platelet count of 100,000 (x 10e6/L) prior to the initiation of a cycle.
- Prothrombin time-international normalized ratio/partial thromboplastin time (PT-INR/PTT) \<1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
- Women of childbearing potential must have a negative urine pregnancy test at baseline.
- Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
- Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
- Subjects must be willing and able to give written informed consent.
- Main part:
- Subjects between the age of 18 and 84 years
- Subjects with locally advanced or metastatic pancreatic adenocarcinoma stage III/IV indicated for gemcitabine treatment as determined by the investigator
- No option for surgical resection or radiation in curative intent
- Histological or cytological documentation of non-hematologic, malignant solid tumor
- At least one measurable lesion or evaluable disease, as per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
- Life expectancy of at least 3 months
- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Alanine aminotransferase (ALT) \<=3.0 x upper limit of normal (ULN; \<=5 x ULN for subjects with liver metastases)
- Aspartate aminotransferase (AST) \<=3.0 x ULN (\<=5 x ULN for subjects with liver involvement with cancer)
- Total bilirubin \<=2.0 x ULN (liver metastasis \<=5 x ULN)
- Serum creatinine \<=1.5 x ULN
- Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 10e6/L) and platelet count of 100,000 (x 10e6/L) prior to the initiation of a cycle.
- Prothrombin time-international normalized ratio/partial thromboplastin time (PT INR/PTT) \<1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
- Women of childbearing potential must have a negative urine pregnancy test at baseline.
- Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
- Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
- Subjects must be willing and able to give written informed consent.
Exclusion
- Lead-in safety period:
- 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
- Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) \>=7%
- Poorly controlled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management
- Poorly controlled seizure disorder
- Subjects undergoing renal dialysis
- Known hypersensitivity to the study drugs or active substances or excipients of the preparations
- Pregnant or breast feeding
- Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject's record
- Previous participation in this study
- Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study.
- Subject is a relative of, or staff directly reporting to the investigator.
- Subject is an employee of the sponsor.
- Subject is committed under official or judicial order.
- Any other reason that the investigator considers makes the subject unsuitable to participate
- Main part:
- 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
- Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) \>=8%
- Poorly controlled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management
- Poorly controlled seizure disorder
- Subjects undergoing renal dialysis
- 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.
- Radiotherapy to target lesions during study or before study start
- Known hypersensitivity to the study drugs or active substances or excipients of the preparations
- Pregnant or breast feeding
- Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject's record
- Previous participation in this study
- Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study.
- Subject is a relative of, or staff directly reporting to the investigator.
- Subject is an employee of the sponsor.
- Subject is committed under official or judicial order.
- Any other reason that the investigator considers makes the subject unsuitable to participate
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01808638
Start Date
March 1 2013
End Date
January 1 2016
Last Update
March 11 2016
Active Locations (9)
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1
Charité - Universitätsmedizin Berlin Charité Centrum für Tumormedizin
Berlin, Germany, 13353
2
Klinikum Dortmund gGmbH Medizinische Klinik Mitte
Dortmund, Germany, 44137
3
Universitätsklinikum Freiburg, Innere Medizin II
Freiburg im Breisgau, Germany, 79106
4
Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne
Herne, Germany, 44625