Clinical trialPhase 1 / Phase 2Completed
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
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- March 2013
- Expected end
- January 2016
- Enrollment
- 29 participants
- Sites
- 9
- Primary outcomes
- Number of subjects with adverse events; Subject physical examination; Measuring of subject vital signs and body weight; Performance of 12-lead ECG; Assessment of clinically significant laboratory parameters outside normal range
- Sponsor
- Industry
- Results posted
- No
- Last update
- 11 March 2016
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Brief summary public domain (ClinicalTrials.gov)
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.