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

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

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.

Study Overview

• Status: Suspended
• Conditions: Mesothelioma
• Intervention / Treatment: Drug: Oshadi D and Oshadi R

• Study Type: Interventional
• Enrollment (Anticipated): 17
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91240
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oshadi D and Oshadi R; anti cancer agents	Drug: Oshadi D and Oshadi R; anti cancer agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and serious adverse events occurence	Adverse events and serious adverse events report	One month following treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival time	Overall survival time from treatment initiation	12 months

Collaborators and Investigators

• Sponsor: Oshadi Drug Administration

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 25, 2012
• First Posted (ESTIMATE): June 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; Malignant Mesothelioma; Anti cancer agents
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: OS-MES-P2-01