Mesothelioma Clinical Trial
Official title:
A Double-blind, Placebo Controlled, Randomized Multicenter Phase II Study Evaluating Gemcitabine With or Without Ramucirumab as II Line Treatment for Advanced Malignant Pleural Mesothelioma
Study RAMES is a multicentre, double-blind, randomized Phase II study exploring the efficacy and evaluating the safety of the addition of ramucirumab to gemcitabine as the second-line treatment of patients with diffuse pleural mesothelioma. Patients will be randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m2 on days 1 and 8 every 21 days with placebo or combined with intravenous ramucirumab 10 mg/Kg (ramucirumab group) on day 1 of a 21 day cycle until PD. Randomisation will be done via a centralized system and will stratified by performance status (0-1 vs 2), age (≤70 vs >70), histology (epithelioid vs others), time to progression (TTP) after a previous treatment (first line therapy, adjuvant or neoadjuvant therapy) (< 6 months vs ≥6 months).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01950572 -
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
|
||
| Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
| Terminated |
NCT02838745 -
Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM
|
Phase 1 | |
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Recruiting |
NCT01912547 -
Thromboelastography During Surgery for Malignant Pleural Mesothelioma
|
Phase 0 | |
| Completed |
NCT01521325 -
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
|
Phase 1 | |
| Recruiting |
NCT00996385 -
Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma
|
Phase 2 | |
| Recruiting |
NCT02073500 -
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
|
||
| Completed |
NCT02467426 -
Isolated Thoracic Perfusion (ITP-F) for MPM
|
Phase 2 | |
| Completed |
NCT00407459 -
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
|
Phase 2 | |
| Completed |
NCT00787410 -
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
|
Phase 2 | |
| Terminated |
NCT01907100 -
Nintedanib (BIBF 1120) in Mesothelioma
|
Phase 2/Phase 3 | |
| Completed |
NCT04056026 -
A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
|
Early Phase 1 | |
| Completed |
NCT02903914 -
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03319537 -
Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma
|
Phase 1/Phase 2 | |
| Terminated |
NCT03685591 -
PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
|
Phase 1 |