A Study Evaluating Ramucirumab in Children and Young Adults with Synovial Sarcoma.
- Conditions
- Synovial SarcomaMedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004243-23-IT
- Lead Sponsor
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 34
- Patients with either relapsed, recurrent, or refractory SS.
- Patients must be >11 kg at the time of study enrollment.
- The patient has a Lansky (<16 years of age; Lansky et al. 1987) or Karnofsky (=16 years of age; Karnofsky et al. 1948) performance score of at least 50.
- Patients must be 36 months to =29 years of age at the time of study enrolment.
- Patients must
•have measurable disease by RECIST 1.1
•have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy) that contains ifosfamide and/or doxorubicin, and any approved therapies for which they are
eligible, unless the patient is not a suitable candidate for the approved therapy.
•not be eligible for surgical resection at time of enrollment
- Patients must not have received prior exposure to ramucirumab.
- Patient with adequate laboratory values and hematologic, coagulation, liver, cardiac, renal and bladder function, and adequate blood pressure (BP) control as per protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 a known hypersensitivity to ramucirumab , gemcitabine, docetaxel or agents formulated with Polysorbate 80
- 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.
- Patients with CNS involvement are ineligible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- To characterize the PK of ramucirumab when co-administered with gemcitabine and docetaxel in pediatric and young adult patients with SS.<br>- 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: L'analisi primaria avra' inizio quando un evento PFS sara' riscontrato in circa l'80% dei pazienti arruolati
- Secondary Outcome Measures
Name Time Method 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.