drugset / Trial / NCT01627795

Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment

NCT01627795

Phase 1/2 Suspended 17 enrolled Oshadi Drug Administration
NaSingle-groupOpen-labelTreatment

Summary

Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of 4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless of the therapeutic approach. The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12 months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no dose-limiting toxicities observed.

Timeline

Start
2016-12
Primary completion
2018-08
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Oshadi D Protein / enzyme biologic
Subject Oshadi R Protein / enzyme biologic

Indications