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Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02) (Atu027-I-02)

Primary Purpose

Carcinoma, Pancreatic Ductal

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Atu027 & gemcitabine in lead in safety period
Atu027 & gemcitabine in treatment arm 1
Atu027 & gemcitabine in treatment arm 2
Sponsored by
Silence Therapeutics GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Pancreatic Ductal focused on measuring Adenocarcinoma, Pancreas, Gemcitabine, Atu027

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

  • Charité - Universitätsmedizin Berlin Charité Centrum für Tumormedizin
  • Klinikum Dortmund gGmbH Medizinische Klinik Mitte
  • Universitätsklinikum Freiburg, Innere Medizin II
  • Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne
  • Klinikum Kassel GmbH Medizinischen Klinik IV;Onkologie,
  • Klinikum Nürnberg Nord Medizinische Klinik 5
  • Klinik und Poliklinik für Innere Medizin I Universitätsklinikum Regensburg
  • Klinikum Stuttgart Klinik Hämatologie, Onkologie und Palliativmedizin
  • Universitätsklinikum Ulm Zentrum für Innere Medizin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Lead in safety period

Treatment arm 1

Treatment arm 2

Arm Description

Cohort of three subjects with non-pancreatic cancer for whom conventional treatment options have failed, will be treated. If one of the subjects in the safety cohort experiences an unacceptable toxicity, the safety cohort is expanded to six subjects.

Subjects with advanced pancreatic cancer will be treated.

Subjects with advanced pancreatic cancer will be treated.

Outcomes

Primary Outcome Measures

Number of subjects with adverse events
Time frame will be 18 weeks if patient will be withdrawn after 3 cycles because of disease progression or toxicity.
Subject physical examination
Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Measuring of subject vital signs and body weight
End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles. Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Performance of 12-lead ECG
End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles. Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Assessment of clinically significant laboratory parameters outside normal range
Additional time frames in arm 1: During treatment on days 1, 8, 15 of each cycle. Additional time frames in arm 2 and safety cohort (cycle 1 only): During treatment on days 1, 4, 8, 11, 15, 18, 22, 25 of each cycle.
Maximum concentration (Cmax), area under the curve (AUC), time to maximum concentration (tmax), and half life (t½) of the Atu027 siRNA single strand (A-strand), and of AtuFect01 and the helper lipid DPyPE
Additional time frames in arm 1: During cycles 1 and 2 of treatment on days 1, 8, 15 of each cycle; in cycle 3 and following only on day 1; Additional time frames in arm 2 and safety cohort (cycle 1 only): During the first treatment cycle on days 1, 4, 8, 11, 15, 18; in cycle 3 and following odd numbered cycles only on day 1; in all even numbered cycles no samples are taken. Pharmacokinetics will be assessed in subjects of the safety cohort and in the first 4 subjects per treatment arm.

Secondary Outcome Measures

Objective response rate
Response will be assessed by RECIST Version 1.1 using abdominal magnetic resonance imaging (MRI) or computed tomography (CT) scans. An objective response is defined when the overall response is complete response (CR), partial response (PR), or stable disease (SD).
Progression-free survival and overall survival
Progression-free survival and overall survival, based on the objective response definition will be analyzed using Kaplan-Meier methods.
ECOG performance score
Additional time frames: During treatment on day 1 of each cycle. The ECOG performance status, and its change from baseline, will be summarized descriptively by visit and treatment arm. The ECOG performance status will also be assessed during the 1 year follow-up period of the study and results including changes to baseline will be summarized.
Biomarker response
Serum protein markers and circulating microRNA will be analyzed and changes to baseline will be summarized descriptively by treatment arm.
Tumor marker response
Additional time frame: At day 1 of cycle 3 and day 1 of each following second cycle; Tumor markers will be summarized descriptively for each analyzed marker.
Quality of life
Different scales of quality of life assessed with the EORTC questionnaire and their changes from baseline will be summarized descriptively by visit and treatment arm.

Full Information

First Posted
March 4, 2013
Last Updated
March 10, 2016
Sponsor
Silence Therapeutics GmbH
Collaborators
Granzer Regulatory Consulting & Services, FGK Clinical Research GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01808638
Brief Title
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)
Acronym
Atu027-I-02
Official Title
A PHASE Ib/IIa STUDY OF COMBINATION THERAPY WITH GEMCITABINE AND ATU027 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC ADENOCARCINOMA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silence Therapeutics GmbH
Collaborators
Granzer Regulatory Consulting & Services, FGK Clinical Research GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 gemcitabine. This combination aims at enhancing gemcitabine´s anti-tumor activity with Atu027. The objectives of this clinical trial are to evaluate safety and activity of two Atu027 schedules in combination with standard gemcitabine treatment in patients with advanced or metastatic pancreatic adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal
Keywords
Adenocarcinoma, Pancreas, Gemcitabine, Atu027

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lead in safety period
Arm Type
Other
Arm Description
Cohort of three subjects with non-pancreatic cancer for whom conventional treatment options have failed, will be treated. If one of the subjects in the safety cohort experiences an unacceptable toxicity, the safety cohort is expanded to six subjects.
Arm Title
Treatment arm 1
Arm Type
Experimental
Arm Description
Subjects with advanced pancreatic cancer will be treated.
Arm Title
Treatment arm 2
Arm Type
Experimental
Arm Description
Subjects with advanced pancreatic cancer will be treated.
Intervention Type
Drug
Intervention Name(s)
Atu027 & gemcitabine in lead in safety period
Intervention Description
Subjects will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks.
Intervention Type
Drug
Intervention Name(s)
Atu027 & gemcitabine in treatment arm 1
Intervention Description
Subjects will be treated in a 28-day cycle with Atu027 and gemcitabine once weekly for three consecutive weeks (on days 1, 8, and 15). During week four no treatment is administered. Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs.
Intervention Type
Drug
Intervention Name(s)
Atu027 & gemcitabine in treatment arm 2
Intervention Description
Subjects will be treated in a 28-day cycle with gemcitabine once weekly (on days 4, 11, and 18) and Atu027 twice weekly (on days 1, 4, 8, 11, 15, 18, 22, and 25). The 28-day combination cycle is followed by a 28-day gemcitabine monotherapy cycle. Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs.
Primary Outcome Measure Information:
Title
Number of subjects with adverse events
Description
Time frame will be 18 weeks if patient will be withdrawn after 3 cycles because of disease progression or toxicity.
Time Frame
Baseline till follow up visit 1 (18 weeks)
Title
Subject physical examination
Description
Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Time Frame
At baseline; later on in 4 week intervals till last follow up visit (1 year);
Title
Measuring of subject vital signs and body weight
Description
End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles. Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Time Frame
At baseline; end of treatment (13 weeks); later on in 4 week intervals till last follow up visit (1 year)
Title
Performance of 12-lead ECG
Description
End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles. Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Time Frame
At baseline; later on in 4 week intervals till end of treatment (13 weeks)
Title
Assessment of clinically significant laboratory parameters outside normal range
Description
Additional time frames in arm 1: During treatment on days 1, 8, 15 of each cycle. Additional time frames in arm 2 and safety cohort (cycle 1 only): During treatment on days 1, 4, 8, 11, 15, 18, 22, 25 of each cycle.
Time Frame
At baseline; at end of treatment (week 13 if patient withdrawn after 3 cycles); at follow up visit 1 (week 18 if patient withdrawn after 3 cycles); at each follow up visit till end of trial (1 year)
Title
Maximum concentration (Cmax), area under the curve (AUC), time to maximum concentration (tmax), and half life (t½) of the Atu027 siRNA single strand (A-strand), and of AtuFect01 and the helper lipid DPyPE
Description
Additional time frames in arm 1: During cycles 1 and 2 of treatment on days 1, 8, 15 of each cycle; in cycle 3 and following only on day 1; Additional time frames in arm 2 and safety cohort (cycle 1 only): During the first treatment cycle on days 1, 4, 8, 11, 15, 18; in cycle 3 and following odd numbered cycles only on day 1; in all even numbered cycles no samples are taken. Pharmacokinetics will be assessed in subjects of the safety cohort and in the first 4 subjects per treatment arm.
Time Frame
At end of treatment (week 13 if patient withdrawn after 3 cycles); at follow up visit 1 (week 18 if patient withdrawn after 3 cycles)
Secondary Outcome Measure Information:
Title
Objective response rate
Description
Response will be assessed by RECIST Version 1.1 using abdominal magnetic resonance imaging (MRI) or computed tomography (CT) scans. An objective response is defined when the overall response is complete response (CR), partial response (PR), or stable disease (SD).
Time Frame
At baseline and in 8 week intervals till end of trial (1 year)
Title
Progression-free survival and overall survival
Description
Progression-free survival and overall survival, based on the objective response definition will be analyzed using Kaplan-Meier methods.
Time Frame
From baseline in 8 week intervals till end of trial (1 year).
Title
ECOG performance score
Description
Additional time frames: During treatment on day 1 of each cycle. The ECOG performance status, and its change from baseline, will be summarized descriptively by visit and treatment arm. The ECOG performance status will also be assessed during the 1 year follow-up period of the study and results including changes to baseline will be summarized.
Time Frame
At baseline; at end of treatment (13 weeks if patient withdrawn after 3 cycles); at follow up visit 1 (18 weeks if patient withdrawn after 3 cycles); at each following follow up visit till end of trial (1 year)
Title
Biomarker response
Description
Serum protein markers and circulating microRNA will be analyzed and changes to baseline will be summarized descriptively by treatment arm.
Time Frame
At baseline; at day 1 of cycle 3; end of treatment (13 weeks if patient withdrawn after 3 cycles); follow up visit 1 (18 weeks if patient withdrawn after 3 cycles)
Title
Tumor marker response
Description
Additional time frame: At day 1 of cycle 3 and day 1 of each following second cycle; Tumor markers will be summarized descriptively for each analyzed marker.
Time Frame
At baseline; at end of treatment (13 weeks if patient withdrawn after 3 cycles); at follow up visit 1 (18 weeks if patient withdrawn after 3 cycles); at each following follow up visit till end of trial (1 year)
Title
Quality of life
Description
Different scales of quality of life assessed with the EORTC questionnaire and their changes from baseline will be summarized descriptively by visit and treatment arm.
Time Frame
At baseline; at day 1 of all cycles except cycle 1; at end of treatment (week 13 if patient withdrawn after 3 cycles)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Strumberg, Prof.Dr.med.
Organizational Affiliation
Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin Charité Centrum für Tumormedizin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinikum Dortmund gGmbH Medizinische Klinik Mitte
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Innere Medizin II
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Klinikum Kassel GmbH Medizinischen Klinik IV;Onkologie,
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Klinikum Nürnberg Nord Medizinische Klinik 5
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Klinik und Poliklinik für Innere Medizin I Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Klinikum Stuttgart Klinik Hämatologie, Onkologie und Palliativmedizin
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Universitätsklinikum Ulm Zentrum für Innere Medizin
City
Ulm
ZIP/Postal Code
89061
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33114652
Citation
Schultheis B, Strumberg D, Kuhlmann J, Wolf M, Link K, Seufferlein T, Kaufmann J, Feist M, Gebhardt F, Khan M, Stintzing S, Pelzer U. Safety, Efficacy and Pharcacokinetics of Targeted Therapy with The Liposomal RNA Interference Therapeutic Atu027 Combined with Gemcitabine in Patients with Pancreatic Adenocarcinoma. A Randomized Phase Ib/IIa Study. Cancers (Basel). 2020 Oct 26;12(11):3130. doi: 10.3390/cancers12113130.
Results Reference
derived

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Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)

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