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 - A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with metastatic colorectal cancer (APOLLON study)

Takeda Pharmaceutical Company Limited0 sites52 target enrollmentNovember 20, 2015

Conditionsunresectable advanced colorectal cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: unresectable advanced colorectal cancer
Sponsor: Takeda Pharmaceutical Company Limited
Enrollment: 52
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 20, 2015

End Date

March 30, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Takeda Pharmaceutical Company Limited

Eligibility Criteria

Inclusion Criteria

Not provided

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