Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment
NCT01627795 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2018-04-18
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.
Conditions
Interventions
- DRUG
-
Oshadi D and Oshadi R
anti cancer agents
Sponsors & Collaborators
-
Oshadi Drug Administration
lead INDUSTRY
Principal Investigators
-
Hovav Nehushtan, Prof. · Hadassah Medical Organization
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2018-08-31
- Completion
- 2018-12-31
Countries
- Israel
Study Locations
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