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A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

NCT03750786

Description:

This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer
  • Official Title: A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: ISO-CC-007
  • NCT ID: NCT03750786

Conditions

  • Colo-rectal Cancer

Interventions

DrugSynonymsArms
ArfolitixorinGroup A
LeucovorinGroup B

Purpose

This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
  • Arfolitixorin
Group BActive ComparatormFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
  • Leucovorin

Eligibility 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, 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 <5 mm
             reconstruction interval) obtained within 28 days of randomization.

          5. Life expectancy of more than 4 months.

          6. ECOG performance status 0 or 1.

          7. Hemoglobin (Hb) > 100 g/L, Absolute neutrophil count (ANC) > 1.5x109/L. Thrombocytes >
             100x109/L.

          8. Creatinine clearance > 50 mL/min, Total bilirubin < 1.5 x ULN, AST and ALT < 3 x ULN
             (and < 5 x ULN in case of liver metastases).

          9. Male or female ≥18 years of age.

         10. Female patients of childbearing potential must have a negative urine pregnancy test
             and use adequate contraceptive measures . Male patients must use adequate
             contraceptive measures .

         11. Voluntarily signed informed consent before performance of any study related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the patient at any time without prejudice to future medical care.

        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/surgery, 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
             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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:Until disease progression, an average of ten months
Safety Issue:
Description:Best ORR, defined as the best response recorded from the start of the study treatment until the end of treatment.

Secondary Outcome Measures

Measure:Progression free survival
Time Frame:Until disease progression, an average of ten months
Safety Issue:
Description:PFS, defined as the time from randomization to first occurrence of tumor progression based on CT-scans/MRIs.
Measure:Duration of response
Time Frame:Until disease progression, an average of ten months
Safety Issue:
Description:The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Isofol Medical AB

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