A Phase I/II Trial of TG01 and Gemcitabine as adjuvant therapy for treating patients with pancreatic cancer

Phase 1

• Conditions: Adenocarcinoma of the Pancreas; MedDRA version: 15.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002400-40-NO
• Lead Sponsor: Targovax AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-28
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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 < 1.5 mg/dl)
Albumin = 2.5 g/dl
5. 18 years of age or older.
6. ECOG performance status (PS) of 0-1.
7. Life expectancy of at least 6 months
8. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
9. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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)

Study & Design

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