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Gland and Hormone Related Diseases

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Carcinoma, Pancreatic Ductal

Carcinoma, Ductal

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Gemcitabine

Pancrelipase

Pancreatin

Antimetabolites

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 will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks.

Atu027 & gemcitabine in lead in safety period

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.

Atu027 & gemcitabine in treatment arm 1

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.

Atu027 & gemcitabine in treatment arm 2

Dirk Strumberg, Prof.Dr.med.

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.

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

A PHASE Ib/IIa STUDY OF COMBINATION THERAPY WITH GEMCITABINE AND ATU027 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC ADENOCARCINOMA

Time frame will be 18 weeks if patient will be withdrawn after 3 cycles because of disease progression or toxicity.

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.

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.

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.

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.

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, based on the objective response definition will be analyzed using Kaplan-Meier methods.

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.

Serum protein markers and circulating microRNA will be analyzed and changes to baseline will be summarized descriptively by treatment arm.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)	NCT01808638	Carcinoma, Panc...	Atu027 & gemcit... Atu027 & gemcit... Atu027 & gemcit...	18 Years - 84 Years	Silence Therapeutics GmbH
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)	NCT01808638	Carcinoma, Panc...	Atu027 & gemcit... Atu027 & gemcit... Atu027 & gemcit...	18 Years - 84 Years	Silence Therapeutics GmbH
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)	NCT01808638	Carcinoma, Panc...	Atu027 & gemcit... Atu027 & gemcit... Atu027 & gemcit...	18 Years - 84 Years	Silence Therapeutics GmbH

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