JPRN-jRCT2091220285CompletedPhase 2
Phase II trial of Lenvatinib in patients with metastatic or recurrent thymic carcinoma;REMORA trial - NCCH1508,REMORA trial
oboru YamamotoDepartment of Experimental Therapeutics, National Cancer Center Hospital0 sites42 target enrollmentStarted: April 7, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1) Patients with thymic carcinoma confirmed by tissue or cytological diagnosis
- •2) Correspond to any of the following
- •a. Unresectable Masaoka-Koga classification IIIa or IIIb thymic carcinoma
- •b. Masaoka-Koga classification IVa or IVb thymic carcinoma
- •c. Recurrent thymic carcinoma
- •3) Patients who had received at least one previous platinum-based chemo (radio) therapy
- •4) No symptomatic brain metastasis, carcinomatous meningitis, vertebral metastasis requiring radiotherapy or surgery
- •5) No cardiac effusion, pleural effusion and ascites requiring any treatment
- •6) Aged 20 or above at the time of registration
- •7) Performance Status 0 or 1
- •8) Oral intake
- •9) One or more measurable lesions confirmed by contrast enhanced CT
- •10) No prior treatment of agents targeting the VEGFR
- •11) Not received anti-cancer therapy within 14days before registration
- •12) Not having any of the following histories/complications
- •a. History of hypertensive crisis or hypertensive encephalopathy
- •b. History of surgery under general anesthesia within 28days before registration
- •c. History of total gastrectomy
- •d. Unrecovered wound, active gastrointestinal ulcer
- •e. Congenital hemorrhagic diathesis or coagulation disorder
- •13) Adequately controlled blood pressure
- •14) Patients in laboratory tests performed within 14 days before registration
- •15) Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration
- •16) Given consent to contraception
- •17) Written informed consent
Exclusion Criteria
- •1) Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible
- •2) Infections requiring systemic therapy
- •3) Fever of >=38 degrees Celsius at the time of registration
- •4) Active hemoptysis (more than half a teaspoon of blood) within 21days before registration
- •5) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations
- •6) Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia
- •7) History of any of the followings; unstable angina within 6 months before registration, heart attack, pulmonary embolism, deep vein thrombosis, brain bleeding, cerebral infarction, transient ischemic attacks within 6 months before registration and arterial thromboembolism
- •8) HIV antibody positive
- •9) Pregnant or breast-feeding women, or women suspected of being pregnant
- •10) Mental disease interfering taking part in the trial
- •11) Taking continuous systemic steroids and/or other immunosuppressive drugs (orally or intravenously)
Investigators
Similar Trials
Completed
Phase 2
Phase II trial of Lenvatinib in patients with metastatic or recurrent thymic carcinoma;REMORA trial (NCCH1508,REMORA trial)Thymic carcinomaJPRN-UMIN000026777ational Cancer Center42
Completed
Phase 2
A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial)colorectal cancerJPRN-UMIN000023446ational Cancer Center30
Active, not recruiting
Phase 1
A phase II study to evaluate the safety and efficacy of lenvatinib in patients with advanced grade 1/2 neuroendocrine neoplasmas of pancreatic and extrapancreatic origin.EUCTR2015-001467-39-ITGETNE (GRUPO ESPAñOL DE TUMORES NEUROENDOCRINOS)110
Not yet recruiting
Unknown
Multicenter phase II trial of lenvatinib in patients with unresectable or metastatic hepatocellular carcinoma after progression on first-line atezolizumab plus bevacizumabKCT0008607Asan Medical Center50
Active, not recruiting
Phase 1
Phase 2 trial of ponatinib in patients with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure or intolerance of prior therapy with imatinib (POETIG trial – POnatinib after rEsisTance to Imatinib in GIST)EUCTR2015-002285-23-DEniversitaetsklinikum Essen81