Adenocarcinoma of the Pancreas MedDRA version: 15.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: TG01
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Not available
Current Sponsor code: 12A
Other descriptive name: 12-A- p21 RAS(5-21)
Concentration u
Sponsors
Targovax AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas 2. Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria). 3. Successful surgical resection: Complete resection (R0) or with microscopic residual disease (R1) Able to receive TG01 treatment within 2-8 weeks following surgery 4. Laboratory Values: Absolute neutrophil count = 1.5 x 109/l Platelets = 100 x 109/l Haemoglobin = 10 g/dl Total bilirubin = 1.5 x UNL AST or ALT = 2.5 x UNL Creatinine clearance = 60 ml/min calculated by the Cockcroft-Gault formula (serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Has received an investigational drug within 4 weeks prior to Trial drug administration 2. Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy) 3. Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma) 4. Has any other serious illnesses or medical conditions such as, but not limited to: Any uncontrolled infection Uncontrolled cardiac failure classification III or IV (NY Heart Association) Uncontrolled systemic and gastro-intestinal inflammatory conditions Bone marrow dysplasia History of auto-immune disease History of adverse reactions to vaccines 5. Known history of positive tests for HIV/AIDS, hepatitis B or C 6. Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential) 7. Contraindication to Gemcitabine treatment 8. Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer) 9. Known malignant brain lesion(s) 10. Significant weight loss before surgery (=10% weight loss)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the potential for interference of Gemcitabine on immune response to TG01 as determined by TG01 specific DTH skin test reaction and T-cell function in peripheral blood in patients receiving TG01 and GM-CSF after primary resection of pancreatic adenocarcinoma ;Secondary Objective: The secondary objectives of the study are: To assess the safety of Gemcitabine given concomitantly with TG01/GM-CSF vaccination To assess the efficacy of TG01 and GM-CSF in patients with resected pancreatic cancer The exploratory objective is: To assess the relationship of KRAS status to recurrence ;Primary end point(s): Primary: • Immune response (DTH responses and proliferative T-cell responses) ;Timepoint(s) of evaluation of this end point: By week 11 and at end of the treatment period with Gemcitabine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: • Safety (adverse events and laboratory assessments) • Efficacy (DFS and overall survival) Exploratory: Relationship between KRAS status and recurrence ;Timepoint(s) of evaluation of this end point: Assessed during the study until the end of the study. No specific timepoint. | — |
Countries
Norway, Spain, United Kingdom
Contacts
Public ContactAndrew Pegg
Aptiv Solutions (UK) Limited
Outcome results
None listed