Synovial Sarcoma MedDRA version: 20.0 Level: PT Classification code 10042863 Term: Synovial sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with either relapsed, recurrent, or refractory SS. - Patients must be 12 months to =29 years of age at the time of study enrolment. - Patients must have received at least one prior line of systemic treatment, have measurable disease by RECIST 1.1, and must not be eligible for surgical resection at time of enrolment. - Patients who have a Lansky (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who have had allogeneic bone marrow or solid organ transplant are excluded. - Patients who have active infections requiring therapy. - Patients who have a history of fistula, gastrointestinal (GI) ulcer or perforation, or intra-abdominal abscess within 3 months of study enrolment are not eligible. - Patients with a bowel obstruction, extensive intestinal resection or history or presence of inflammatory enteropathy or other GI pathology as per protocol. - Patients with a history of hepatorenal syndrome. - Patients with evidence of active bleeding or a history of significant (= Grade 3) bleeding event, deep vein thrombosis requiring medical intervention (including pulmonary embolism), hemoptysis or other signs of pulmonary haemorrhage, or esophageal varices within 3 months of enrollment are not eligible. - Patients with a bleeding diathesis or vasculitis are not eligible. - Patients with a history of central nervous system (CNS) arterial/venous thromboembolic events (VTEs) including transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of study enrolment are not eligible. - Patients with myocardial infarction or unstable angina within the prior 6 months. - Patients with significant vascular disease or peripheral vascular disease. - Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrolment are not eligible. - Patients who have non-healing wound, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrolment are not eligible. - Patients previously treated and progressed on combination gemcitabine or docetaxel. (Patients who received combination as maintenance therapy, without progression, would be eligible.) - Patients with a known hypersensitivity to gemcitabine, docetaxel or agents formulated with Polysorbate 80. - Patients who have previously received any exposure to ramucirumab are not eligible. - Patients with clinical or radiologic findings consistent with interstitial pneumonia or pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ramucirumab in combination with gemcitabine and docetaxel compared with gemcitabine and docetaxel in pediatric and young adult patients with SS (SS = synovial sarcoma).;Secondary Objective: - To evaluate the safety and tolerability of ramucirumab in combination with gemcitabine and docetaxel compared with gemcitabine and docetaxel in pediatric and young adult patients with SS. - To characterize the PK of ramucirumab when co-administered with gemcitabine and docetaxel in pediatric and young adult patients with SS. - To assess the immunogenicity of ramucirumab when co-administered with gemcitabine and docetaxel in pediatric and young adult patients with SS.;Primary end point(s): progression-free survival (PFS);Timepoint(s) of evaluation of this end point: The primary analysis will be triggered when PFS events have occurred for approximately 80% of the enrolled patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Serious adverse event, Adverse event, Safety laboratory assessments, Vital signs, overall response rate, Duration of response, Complete response, Cmax (maximum concentration), Cmin (minimum concentration) and Incidence of immunogenicity;Timepoint(s) of evaluation of this end point: Throughout study. | — |
Countries
Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed