A clinical trial in phase 2 of development which will be conducted in multiple centers, a nonactive substance will be used as a comparator, all patients will receive standart of care therapy for the conditition together with the study drug or nonactive substunce. No one of the involved parties will be know what is the included patients's therapy regiments. The purpose of the trial is to assess the efficacy and safety of the study drug and its ability to triger the immune system.

• Conditions: Pancreatic Cancer, post resection R0/R1 status, with tumor sequence confirmation of Ras mutations; MedDRA version: 17.0Level: LLTClassification code 10033575Term: Pancreas cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-005386-35-BG
• Lead Sponsor: GlobeImmune, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1 Subjects must have resectable pancreas cancer, ductal adenocarcinoma type, with post-resection confirmation of non-metastatic disease.
2 Confirmed product related mutation in Ras from tumor sample.
3 ECOG performance status (PS) of =2 prior to randomization.
4 Confirmed R0 or R1 status post-resection.
5 Negative scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.
6 Age =18 years.
7 Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1 Non-resectable pancreatic cancer, or histologic types other than ductal adenocarcinoma (e.g. papillary cystoadenocarcinoma, mucinous cystoadenocarcinoma). Tumors classified as T4.
2 Prior chemotherapy, radiation therapy, targeted therapy, or immunotherapy for pancreatic cancer.
3 History of another cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma of the skin, Stage 1A cervical cancer, or melanoma in situ.
4 History of splenectomy.
5 History of Crohn’s disease or ulcerative colitis.
6 History of major organ transplantation.
7 Concurrent and chronic therapy with corticosteroids (greater than 10 mg per day of prednisone or an equipotent dose of another corticosteroid) or any other immunosuppressive drugs. Use of dexamethasone as an antiemetic during gemcitabine dosing will be permitted during the trial.
8 History of allergy to S. cerevisiae.
9 Presence of an unstable or poorly controlled medical condition that in the opinion of the principal investigator may impair the ability of the subject to participate safely or to potentially benefit from the study.
10 Pregnancy and nursing mothers.
11 Alcohol and/or IV drug abuse within the past year.
12 Participation in any experimental treatment protocol or therapy within 28 days before screening (experimental peri-operative procedures such as the use of novel drains which are anticipated to affect the acute post-operative course, may be allowed after discussion with the medical monitor).
13 History of autoimmune disease (subjects with a history of resolved autoimmune thyroiditis may be eligible with consultation of the study medical monitor).
14 Known history of hypersensitivity to gemcitabine.
15. High risk for noncompliance with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified