None listed
Conditions
Interventions
Drug : In the combotherapy arm, Everolimus (5 mg) and Lenvatinib (14 mg) will be administered orally once daily (QD) in continuous 28-day cycles. In subjects who maintain toxicity at Grade =2 during t
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed advanced Osteosarcoma, Ewing sarcoma, Chondrosarcoma with 1-2 prior chemotherapy : neoadjuvnat or adjuvant chemotherapy is counted as one regimen 2)Age =15 years, <80 years 3)ECOG performance status of 0-1 4)Has at least 1 measurable lesion (as defined by Response Evaluation Criteria in Solid Tumors Version 1.1). 5)Has adequate organ function defined by the following criteria: -Hb = 9.0 g/dL -Absolute neutrophil count (ANC) = 1000 /µL -Platelet = 75,000/ µL -Serum Creatinine: = 50 mL/min -Total Bilirubin: = 1.5 × UNL (upper normal limit) -AST(SGOT)): = 3.0 × UNL or = 5.0 × UNL (in patients with liver metastasis) -ALT(SGPT): = 3.0 × UNL or = 5.0 × UNL (in patients with liver metastasis) 6)Female patient of childbearing potential has a negative serum or urine pregnancy test for ß-hCG 7)Able to provide written informed consent and comply with the protocol requirements
Exclusion criteria
Exclusion criteria: ?Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable ?Any previous treatment to lenvatinib or mTOR inhibitor ?Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria ?Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of IP ?Active or prior documented autoimmune or inflammatory disorders -including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc. ?History of the following conditions within the past 6 months. -coronary angioplasty or stent placement, myocardial infarction, unstable angina, coronary artery bypass grafting, peripheral arterial disease (Grade III) or congestive heart failure (Grade IV) according to the New York Heart Association classification, thromboembolism (patients on stable anticoagulation for =6 weeks are eligible), hemoptysis, intracranial hemorrhage, or clinically significant gastrointestinal bleeding ?Has an active infection requiring parenteral treatment ?History of another primary malignancy. However, enrollment is permitted in the following cases: -Basal cell or squamous cell carcinoma of the skin after curative resection -Cervical carcinoma in situ after at least 1 year following successful treatment -Patients who have been disease-free for at least 3 years after completion of treatment ?Known or active CNS metastasis and/or carcinomatous meningitis -Participants with previously treated brain metastases are eligible if radiologically stable. ?female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to emply effective birth control from screening to 90 days after the last dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free rate (PFR-6) at 24 weeks will be based on RECIST version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall survival (OS);Safety profile | — |
Countries
Korea, Republic of
Contacts
Public Contactkum-Hee Yun
Yonsei University Health System, Severance Hospital
Outcome results
None listed