Patients with chemotherapy-refractory metastatic colorectal cancer MedDRA version: 14.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Aviscumine
Product Code: CY-503
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Aviscumine
CAS Number: 223577-45-5
Current Sponsor code: CY-503
Other descriptive name: A
Sponsors
Cytavis Biopharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or within 3 months after termination of standard chemotherapy (fluoropyrimidine –based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 2nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study. • No chemotherapy within 4 weeks before treatment start • No residual significant toxicity (greater than NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC AE grade 4 within 4 weeks before treatment start. • No previous treatment with experimental therapies after standard therapies is allowed. • Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating. • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 – 2 • WBC = 3,000/mm3, absolute neutrophil count (ANC) = 1,500/mm3, platelet count =100,000/mm3. • Bilirubin = 2.0 mg/dL (40 µmol/L) (unless due to Gilbert’s syndrome in which case the bilirubin should be =3.5 mg/dL (59.86 µmol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) = 5 × upper limit of normal (ULN); hepatic alkaline phosphatase = 3.0 × ULN • Serum creatinine = 2.0 mg/dL (180 µmol/L) or creatinine clearance = 50 ml/min, proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Evidence of any other malignant disease (with the exception of tumours operatively cured at least 5 years prior to the trial) • Known brain metastases • Uncontrolled pleural effusions • Interstitial pneumonitis or pulmonary fibrosis • Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g. alcoholism or substance abuse) • Unstable cardiac disease in the last 6 months • Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial. Ongoing therapy with steroids is permitted if the dose is not higher than 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial. • Any evidence of or history elicited by the investigator of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization • Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin) • History of hypersensitivity to mistletoe • History of primary immunodeficiency • Known human immunodeficiency virus (HIV) or known active viral hepatic infections • Prior treatment with CY-503 • A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this trial is: The assessment of the effect of CY-503 on PFS compared to placebo. ;Secondary Objective: - To assess the effect of CY-503 on overall survival time (OS) in comparison to placebo. - To assess the safety of CY-503. - To assess quality of life based on a standardized questionnaire EORTC QLQ-C30. The effect of CY-503 on immune functions (Translational research);Primary end point(s): PFS (progression free survival) | — |
Countries
Austria, Germany
Outcome results
None listed