First line advanced Colorectal patients eligible for treatment with 5-FU, oxaliplatin, and bevacizumab. MedDRA version: 21.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Isofol Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Colorectal adenocarcinoma verified by biopsy. 2. Availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression. 3. Non-resectable metastatic CRC planned for first line therapy with 5-FU, Leucovorin, oxaliplatin, and bevacizumab. 4. Evaluable disease with at least one measurable lesion of metastatic disease (=10 mm in longest diameter on axial image on CT-scan or alternatively MRI with 80 g/L, Absolute neutrophil count (ANC) > 1.5x109/L. Thrombocytes > 100x109/L. 8. Creatinine clearance > 50 mL/min, Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: 1. Malignant tumors other than colorectal adenocarcinomas (current or within the previous five years), with the exception for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix. 2. Less than 6 months between randomization and completion of the last anti-cancer treatment (chemotherapy/radiotherapy/immunotherapy, etc.). (NB: Rectal cancer treatment shorter than 8 weeks of chemo/radiation therapy is allowed.) 3. Confirmation of progressive disease within 6 months after completion of prior adjuvant anti-cancer treatment. 4. Indication for any metastatic Colo-rectal Cancer (mCRC) surgery or anti-cancer treatment other than study treatment. 5. Prior treatment with arfolitixorin. 6. Indication for treatment with a 5-FU analogue, or 5-FU for a condition other than mCRC. 7. Known Dihydropyrimidine Dehydrogenase Deficiency (DPD) deficiency. 8. Known or suspected central nervous system (CNS) metastases. 9. Unresolved bowel obstruction, uncontrolled Crohn’s disease, or ulcerative colitis. 10. History of cardiac disease with a New York Heart Association Class II or greater, congestive heart failure, myocardial infarction, or unstable angina at any time during the 6 months prior to randomization, or serious arrhythmias requiring medication for treatment. 11. Current CTCAE = grade 3 diarrhea. 12. Current chronic infection or uncontrolled serious illness causing immunodeficiency. 13. Known or suspected hypersensitivity or intolerance to arfolitixorin, LV, 5-FU, oxaliplatin, or bevacizumab. 14. Breastfeeding patients. 15. Patient who received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug, prior to randomization. 16. Patient with serious medical or psychiatric illness likely to interfere with participation in this clinical study. 17. Ongoing drug or alcohol abuse, as deemed by the Investigator. 18. Any condition that, in the opinion of the Investigator, could compromise the patient's safety or adherence to the study protocol. 19. Involvement, or related to people involved in the planning or conduct of the study (applies to both Isofol Medical AB (publ) staff and staff at the study site) 20. Surgery (excluding previous diagnostic biopsy) in the 28-day period before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall response rate (ORR);Secondary Objective: - Progression-free survival (PFS) - Duration of Response (DOR) - Overall survival (OS) - Quality of life - Safety and tolerability - Patients undergoing curative metastasis resection ;Primary end point(s): Best ORR, defined as the best response recorded from the start of the study treatment until the end of treatment. ;Timepoint(s) of evaluation of this end point: All responses will be confirmed by BICR 8 weeks after onset of response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - PFS, defined as the time from randomization to first occurrence of tumor progression assessed by BICR (RECIST 1.1) based on CT-scans/MRIs conducted every 8 weeks after start of treatment, or death from any cause. - The duration of overall response (DOR) is measured from the first time point at which criteria are met for complete response (CR) or partial response (PR) through the last time point when overall response has been objectively documented. - OS, defined as time from randomization to death from any cause - Quality of Life assessed using the EQ-5D patient reported outcome questionnaire (PRO). - Safety & tolerability defined as number and severity of adverse events (AEs), including clinically significant abnormal laboratory findings, regardless of causal relationship to arfolitixorin or LV. Specific AEs will be followed using PRO (NCI PRO-CTCAE). - Patients undergoing curative metastasis resection defined as the number of patients qualifying for curative metastasis resection after treatment with study drug. ;Timepoint(s) of evaluation of this end point: PFS, DOR and EQ-5D will be assessed every 8 weeks after start of treatment. OS will be assessed every 12 weeks after the End of Treatment Visit Safety and tolerability will ba assessed at each timepoint until the End of Treatment Visit Patient undergoing curative metastasis resection will ba assessed at the End of Treatment Visit | — |
Countries
Australia, Austria, Canada, France, Germany, Greece, Japan, Spain, Sweden, United States
Contacts
Public ContactKarin Gedda
Isofol Medical AB
Outcome results
None listed