None listed
Conditions
Interventions
APPROXIMATELY 95 PATIENTS WITH MEASURABLE, NONRESECTABLE LOCALLY ADVANCED OR METASTATIC COLORECTAL ADENOCARCINOMA, WHO HAVE FAILED FIRST-LINE CHEMOTHERAPY, WILL BE ENROLLED IN THE STUDY (APPROXIMATELY
Sponsors
Eisai Inc.,
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. MALE OR FEMALE PATIENT ≥ 18 YEARS OF AGE; 2. HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED NONRESECTABLE LOCALLY ADVANCED OR METASTATIC COLORECTAL ADENOCARCINOMA; 3. PATIENTS MUST HAVE FAILED A FIRST-LINE CHEMOTHERAPY REGIMEN FOR NONRESECTABLE LOCALLY ADVANCED OR MCRC (FIRST-LINE 5-FU-BASED THERAPIES, INCLUDING BUT NOT LIMITED TO FOLFOX, FOLFOX 4, MFOLFOX6, CAPEOX, SINGLE-AGENT CAPECITABINE, INFUSIONAL 5-FU, OR OTHER CHEMOTHERAPIES. BEVACIZUMAB, CETUXIMAB, PANITUMUMAB, AND EGFR INHIBITORS ARE ALLOWED. PRIOR TREATMENT WITH IRINOTECAN OR FOLFIRI IS NOT ALLOWED FOR PHASE II). FOR PHASE IB ONLY, UP TO 3 PRIOR THERAPIES ARE ALLOWED (INCLUDING IRINOTECAN-CONTAINING THERAPIES AND ADJUVANT THERAPY); 4. AT LEAST 1 SITE OF MEASURABLE DISEASE BY THE RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST V. 1.1) CRITERIA; 5. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG, APPENDIX 7) PERFORMANCE STATUS (PS) OF ≥ 2; 6. PATIENTS MUST HAVE ADEQUATE RENAL FUNCTION AS EVIDENCED BY SERUM CREATININE 50 ML/MIN PER THE COCKCROFT GAULT FORMULA.
Exclusion criteria
Exclusion criteria: 1. RECEIVED CHEMOTHERAPY, TARGETED THERAPY, RADIOTHERAPY, SURGERY, IMMUNOTHERAPY, OR TREATMENT IN ANOTHER CLINICAL STUDY WITHIN THE 30 DAYS PRIOR TO COMMENCING STUDY TREATMENT OR HAVE NOT RECOVERED FROM SIDE EFFECTS OF ALL TREATMENT-RELATED TOXICITIES TO GRADE ≤ 1, EXCEPT FOR PERIPHERAL NEUROPA Y (GRADE 1 AND GRADE 2 ARE PERMITTED) AND ALOPECIA; 2. PREVIOUSLY RECEIVED IRINOTECAN OR IRINOTECAN DERIVATIVES IN PHASE II (IRINOTECAN-CONTAINING REGIMENS ARE ALLOWED IN PHASE IB) 3. PREVIOUSLY RECEIVED ANTI-ALPHA INTEGRIN THERAPY; 4. HISTORY OF OTHER MALIGNANCIES EXCEPT: (1) ADEQUATELY TREATED BASAL OR SQUAMOUS CELL CARCINOMA OF THE SKIN; (2) CURATIVELY TREATED IN SITU CARCINOMA OF THE UTERINE CERVIX; OR (3) OTHER CURATIVELY TREATED SOLID TUMOR WITH NO EVIDENCE OF DISEASE FOR ≥ 5 YEARS; 5. PRESENCE OF BRAIN METASTASES, UNLESS THE PATIENT HAS RECEIVED ADEQUATE TREATMENT AT LEAST 4 WEEKS PRIOR TO RANDOMIZATION , AND IS STABLE, ASYMPTOMATIC, AND OFF STEROIDS FOR AT LEAST 4 WEEKS PRIOR TO RANDOMIZATION; 6. ARE CURRENTLY RECEIVING ANY OTHER ANTICANCER TREATMENT; 7. SERIOUS NON-HEALING WOUND, ULCER, OR ACTIVE BONE FRACTURE;
Countries
Argentina, Australia, Brazil, Russian Federation, Ukraine, United States
Outcome results
None listed