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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01627795
• Other study ID #: OS-MES-P2-01
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: June 20, 2012
• Last updated: April 16, 2018
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 17
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Mesothelioma

Intervention

Drug:
• Oshadi D and Oshadi R
anti cancer agents

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and serious adverse events occurence	Adverse events and serious adverse events report	One month following treatment initiation
Secondary	overall survival time	Overall survival time from treatment initiation	12 months