A Single-center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment - A Phase IIa Study
- 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 and alkaline phosphatase must be < 1.5 times
of the upper limit of normal.
- LDH < 500 int. unit/L
- Estimated GFR > 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.
- Evidence of liver metastasis
- Any bone involvement
- Prior radiotherapy, cytotoxic or biologic systemic treatment
- Any history of Asthma or COPD 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
- 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
- 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 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.