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

Oshadi Drug Administration

Status and phase

Suspended

Phase 2

Phase 1

Conditions

Mesothelioma

Treatments

Drug: Oshadi D and Oshadi R

Study type

Interventional

Funder types

Industry

Identifiers

NCT01627795

OS-MES-P2-01

Details and patient eligibility

About

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.

Enrollment

17 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically proven diagnosis of malignant mesothelioma
Man or woman 21 years and above
Adequate performance status (ECOG 0, 1, or 2)
Patient must have adequate organ function as the following:
- Absolute neutrophils counts (ANS) > 2500/μL.
- Platelets > 150,000/μL.
- Hemoglobin > 10 g/dL.
- Total Bilirubin < 1.5 Upper Normal Limit (UNL).
- Alanine aminotransferase (ALT), AST (aspartate aminotransferase)and alkaline phosphatase must be < 1.5 times of the upper limit of normal.
- LDH (lactate dehydrogenase) < 500 int. unit/L
- Estimated GFR (glomerular filtration rate) > 45 ml/min.
Written informed consent
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion criteria

Evidence of liver metastasis
Any bone involvement
Prior radiotherapy, cytotoxic or biologic systemic treatment
Any history of Asthma or COPD (chronic obstructive pulmonary disease) that needs systemic therapy with steroids for more than 2 weeks during the last 2 years.
Treatment with systemic steroids for more then 1 month during the last year.
Active smokers that are unable to quite smoking
Any treatment with investigational agent within 30 days prior to registration for protocol therapy.
Cerebrovascular accident, transient ischemic attack or myocardial infarction within 6 months prior to registration for protocol therapy.
Evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
Any history of solid or hematologic malignancies.
Patient with positive HIV serology at screening.
Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
Uncontrolled hypertension (> 150/100 mm Hg despite optimal medical therapy).
Evidence of ongoing cardiac dysrhythmias of NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 grade 2.
Patients in whom radiation or surgery is indicated
Significant swallowing disorders.
Small bowel surgery.
Suspicion of absorption disruption as a result of abdominal radiation
Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
Evidence of concurrent (< 5 years) second malignancy
Mental disorders.
Inability to give written informed consent.