NCT01808638

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Silence Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Pancreatic Ductal

Interventions

Type	Name	Description
DRUG	Atu027 & gemcitabine in lead in safety period	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.
DRUG	Atu027 & gemcitabine in treatment arm 1	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.
DRUG	Atu027 & gemcitabine in treatment arm 2	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-08-01
• Completion: 2016-01-01
• First posted: 2013-03-11
• Last updated: 2016-03-11

Locations

9 sites across 1 country: Germany