A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapy
- Conditions
- unresectable advanced colorectal cancer
- Registration Number
- JPRN-UMIN000019876
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 52
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: DLT rate (1st course: 4 weeks) Phase II: PFS rate at 6 months
- Secondary Outcome Measures
Name Time Method 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