Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male and female subjects older than 18 years of age
Histologically confirmed colorectal carcinoma
Radiological confirmation of unresectable advanced colorectal carcinoma (AJCC Stage IV) prior to start of initial first-line therapy
At least one measurable lesion according to RECIST measured within 2 weeks prior to treatment start in case of partial response or stable disease
Prior initial first-line therapy included oral or intravenous fluoropyrimidines/leucovorin,irinotecan or oxaliplatin with or without a standard dose of bevacizumab lasted between 4.5 and 6 months and finished (last day of last cycle) within 2 weeks prior to treatment start (treatment duration with irinotecan or oxaliplatin should not be less than 3 months)
Patients who achieved disease control measured as objective response or disease stabilization after initial first-line therapy
No curative standard therapy is available for the patient after first-line treatment
ECOG performance status 0-1
Adequate organ function, hemoglobin ≥ 9 g/L, white blood cell count (WBC) ≥ 3.0 x 109/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets > 100 x109/L, aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, bilirubin < 1.5 x ULN, blood creatinine ≤ 1.5 X ULN, prothrombin time (PT) and activated thromboplastin time (aPTT) within normal range
Negative pregnancy test in women with childbearing potential
Expected adequacy of follow-up
Signed informed consent form (ICF)

Exclusion Criteria:

More than one line of systemic chemotherapy for metastatic colorectal carcinoma
Tumor progression after initial first-line therapy
Clinically significant concomitant diseases or conditions, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
Known central nervous system metastases
Active or uncontrolled infections
Transfusion-dependent anemia
History of autoimmune disease or immune deficiency
Known hypersensitivity to oligonucleotides or excipients of the formulation
Pregnancy and/or nursing
Concurrent chronic systemic immune therapy or immunosuppressant medication, including steroid treatment
Concurrent chemotherapy, hormonal therapy (except hormonal contraception and hormonal replacement therapy for menopausal women), or immunotherapy within the last 2 weeks prior to randomization or during the conduct of the study - Concurrent radiotherapy within the last 6 months prior to randomization or during the conduct of the study
Known HIV seropositivity or active hepatitis B or C infection
Planned major surgery during the study
Participation in another clinical study with other investigational drugs within 30 days prior to the first treatment day
Vaccination within 3 months prior to the first treatment day
Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
Presence of drug and/or alcohol abuse