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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Silence Therapeutics GmbH

Current Primary Outcome:

  • Number of subjects with adverse events [ Time Frame: Baseline till follow up visit 1 (18 weeks) ]
    Time frame will be 18 weeks if patient will be withdrawn after 3 cycles because of disease progression or toxicity.
  • Subject physical examination [ Time Frame: At baseline; later on in 4 week intervals till last follow up visit (1 year); ]
    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 [ Time Frame: At baseline; end of treatment (13 weeks); later on in 4 week intervals till last follow up visit (1 year) ]

    End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles.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 [ Time Frame: At baseline; later on in 4 week intervals till end of treatment (13 weeks) ]

    End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles.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 labor

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Objective response rate [ Time Frame: At baseline and in 8 week intervals till end of trial (1 year) ]

      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 [ Time Frame: From baseline in 8 week intervals till end of trial (1 year). ]
      Progression-free survival and overall survival, based on the objective response definition will be analyzed using Kaplan-Meier methods.
    • ECOG performance score [ 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) ]

      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 [ 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) ]
      Serum protein markers and circulating microRNA will be analyzed and changes to baseline will be summarized descriptively by treatment arm.
    • Tumor marker response [ 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) ]
      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 [ 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) ]
      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.


    Original Secondary Outcome: Same as current

    Information By: Silence Therapeutics GmbH

    Dates:
    Date Received: March 4, 2013
    Date Started: March 2013
    Date Completion:
    Last Updated: March 10, 2016
    Last Verified: March 2016