unresectable advanced colorectal cancer
Conditions
Interventions
Panitumumab+TAS-102 -Panitumumab 6mg/kg/ q2w -TAS-102 35mg/m2 (Day1-5, Day8-12)
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol. (2)Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment (3)Aged 20 to 75 years at the time of informed consent (4)Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer) (5)Patients with lesion(s) that can be evaluated. It is not essential to be evaluated the tumor according to the RECIST ver. 1.1. (6)Patients who have received chemotherapies for metastatic colorectal cancer and are refractory to or failing those chemotherapies* including; fluoropyrimidines, irinotecan, oxaliplatin, and an anti-vascular endothelial growth factor (VEGF) agent. (7)Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing. (8)Patients are able to take medications orally. (9)Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment Neutrophil count 1500/microL Platelet count 100000/microL Hemoglobin 8.0 g/dL Total bilirubin 1.5 mg/dL AST 100 IU/L ( 200 IU/L if liver metastases are present) ALT 100 IU/L ( 200 IU/L if liver metastases are present) Serum creatinine 1.5 mg/dL (10)ECOG performance status (PS) of 0 or 1 (11)Life expectancy of 3 months (90 days) or more after enrollment
Exclusion criteria
Exclusion criteria: (1)Has received anti-EGFR antibodies (cetuximab or panitumumab), regorafenib, or TAS-102. (2)Has had treatment with radiotherapy and/or chemotherapy within 2 weeks (14 days) prior to study drug administration (except for limited field radiation in order to rescue of pain). (3)Known brain metastasis or strongly suspected of brain metastasis (4)Synchronous cancers or metachronous cancers with a disease-free period of 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.). (5)Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.) (6)Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy (7)Any investigational agent received within prior 4 weeks (28 days). (8)Disease requiring systemic steroids for treatment (excluding topical steroids) (9)History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.) (10)Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment. (11)Serious drug hypersensitivity (without allergy to oxaliplatin) (12)Local or systemic active infection requiring treatment, or fever indicating infection (13)NYHA class II or higher heart failure or serious heart disease (14)Active hepatitis B (15)Known HIV infection (16)Peripheral neuropathy of Grade 2 or greater by CTCAE (Japanese edition JCOG version 4.03) (17)Known BRAF mutation (18)Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: DLT rate (1st course: 4 weeks) Phase II: PFS rate at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| OS: Overall survival PFS: Progression free survival RR: Response rate DOR: Duration of response DCR: Disease control rate TTF: Time to treatment failure <Safety>Adverse events | — |
Countries
Japan
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Outcome results
None listed