diffuse malignant pleural mesethelioma MedDRA version: 21.0 Level: LLT Classification code 10035605 Term: Pleural mesothelioma malignant advanced System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CYRAMZA - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO) 10 ML- 1 FLACONCINO
Product Name: CYRAMZA
Product Code: [CYRAMZA]
Pharmaceutical Form: Conce
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has a histopathologically or cytologically confirmed diagnosis of malignant pleural mesothelioma. 2. The patient has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy. 3. The patient received combination chemotherapy prior to disease progression. 4. The patient has metastatic disease or locally advanced disease that is measurable, or nonmeasurable but evaluable, by radiological imaging[…]. 5. The patient has an ECOG performance status of 0-2. 6. The patient has adequate organ function, including: a. Total bilirubin ¿1.5×the upper limit of institutional normal (ULN) and ALT and AST¿3 × ULN. b. Serum creatinine ¿1.5 × ULN. c. Urinary protein is =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. The patient has cancer with histology other than mesothelioma. 2. The patient is receiving chronic therapy with any of the following within 7 days prior to randomization: a. NSAIDs; b. other anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted. 3. The patient received radiotherapy within 14 days prior to randomization. 4. The patient received >1 line of prior therapy for the treatment MPM. 5. The patient received previous treatment with agents targeting the VEGF/VEGF Receptor 2 signaling pathway, including previous exposure to ramucirumab. 6. The patient has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. 7. The patient has a significant bleeding disorder or vasculitis or had a Grade ¿3 bleeding episode within 12 weeks prior to randomization. 8. The patient experienced any arterial thromboembolic event (ATE), including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. 9. The patient has symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia. 10. The patient has uncontrolled hypertension, prior to initiating study treatment, despite antihypertensive intervention. 11. The patient underwent major surgery within 28 days prior to randomization or central venous access device placement within 7 days prior to randomization. The patient has a serious or nonhealing wound, ulcer or bone fracture within 28 days prior to enrollment. 12. The patient has selective or planned major surgery to be performed during the course of clinical trial. 13. The patient has a history of gastrointestinal perforation or fistula within 6 months prior to randomization. 14. The patient has a history of inflammatory bowel disease or Crohn’s disease requiring medical ¿12 months prior to randomization. 15. The patient has an acute or subacute bowel obstruction or history of chronic diarrhea that is considered clinically significant in the opinion of the investigator. 16. The patient has either of the following: a. cirrhosis at a level of Child-Pugh B. b. cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. 17. The patient has known allergy or hypersensitivity to any components of study treatment. 18. The patient received any previous investigational therapy within 4 half –lives of the investigational agent prior to randomization. 19. The patient has a serious illness or medical condition including, but not limited to, the following: a. known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness b. active or uncontrolled clinically serious infection. 20. The patient is pregnant or breast-feeding. 21. The patient has a concurrent active malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of ramucirumab10 mg/kg plus gemcitabine versus gemcitabine with placebo, in terms of OS;Secondary Objective: Evaluate the efficacy of ramucirumab 10 mg/kg plus gemcitabine versus gemcitabine with placebo, in terms of PFS; Safety and tolerability · Objective response rate · Disease control rate · Predictive molecular markers · Quality life;Primary end point(s): Overall survival, as determined by investigator assessment per RECIST 1.1;Timepoint(s) of evaluation of this end point: the date of randomization to the date of death from any cause or the last date the patient was known to be alive | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival, as determined by investigator assessment per RECIST 1.1; The safety endpoints evaluated will include but are not limited to the following: · TEAEs, AESIs, SAEs, and hospitalizations · Clinical laboratory tests, vital signs, and physical examinations · ORR · DCR · polymorphisms assoceted with ramucirumab response; -evaluation of circulating pro-angiogenic factors in response to ramucirumab treatment; · Survey;Timepoint(s) of evaluation of this end point: from the date of randomization to the date of radiographic documentation of progression (as defined by RECIST v1.1) or the date of death due to any cause, whichever is earlier.; from the date to entered in the study until the end of the study | — |
Countries
Italy
Contacts
Public ContactServizio Informazione sulla Sperime
Pharmaceutical Development and Services srl
Outcome results
None listed