Colorectal cancer
Conditions
Interventions
investigational material(s)
Generic name etc : panitumumab, TAS-102
INN of investigational material : panitumumab, trifluridine + tipiracil
Therapeutic category code : 42- Antineoplastic agents
Dosage
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol. 2. Participants who have given written consent to take part in the study after detailed explanation of the study prior to enrollment 3. Aged >=20 to =1.5x10^3/microL - Platelet count >=1.0x10^4/microL - Hemoglobin >=8.0 g/dL - Total bilirubin = 3 months (90 days) 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. Participants 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 diarrhea (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. Adverse event due to previous treatment that has not recovered to Grade 1 (Grade 2 for peripheral sensory neuropathy) by CTCAE (Japanese edition JCOG version 4.03) (excluding hemoglobin content) 17. Known BRAF mutation 18. Other participants judged by the investigator or subinvestigator to be ineligible for enrollment in the study (such as patients who were coerced to give consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants With Dose Limiting Toxicity (DLT) with Panitumumab plus TAS-102 Combination Therapy Timeframe: Up to approximately 1 month DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant. efficacy Progression Free Survival (PFS) Rate at 6 Months Timeframe: Up to 6 months PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Overall Survival (OS) Timeframe: Up to approximately 29 months OS was defined as the period from the day of enrollment until death by all causes. efficacy Progression Free Survival (PFS) Timeframe: Up to approximately 29 months PFS was defined as the period from the day of enrollment until the day of documented progression or the day of death due to all causes whichever comes earlier. Progression will include both PD based on diagnostic imaging assessed according to response evaluation criteria in solid tumors (RECIST) ver 1.1 and primary disease progression that cannot be confirmed by diagnostic imaging (clinical progression). efficacy Response Rate (RR) Timeframe: Up to approximately 29 months RR was defined as the percentage of participants who had shown complete response (CR) or partial response (PR) as the best overall response in accordance with the RECIST 1.1 criteria. The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). efficacy Duration of Response (DOR) Timeframe: Up to approximately 29 months DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier. efficacy Disease Control Rate (DCR) Timeframe: Up to approximately 29 months DCR was defined as the perc | — |
Countries
Japan
Outcome results
None listed