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

Primary Purpose

Mesothelioma

Status
Suspended
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Oshadi D and Oshadi R
Sponsored by
Oshadi Drug Administration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma focused on measuring Malignant Mesothelioma, Cancer, Anti cancer agents

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hadassah Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oshadi D and Oshadi R

Arm Description

anti cancer agents

Outcomes

Primary Outcome Measures

Adverse events and serious adverse events occurence
Adverse events and serious adverse events report

Secondary Outcome Measures

overall survival time
Overall survival time from treatment initiation

Full Information

First Posted
June 20, 2012
Last Updated
April 16, 2018
Sponsor
Oshadi Drug Administration
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1. Study Identification

Unique Protocol Identification Number
NCT01627795
Brief Title
Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Suspended
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oshadi Drug Administration

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
Malignant Mesothelioma, Cancer, Anti cancer agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oshadi D and Oshadi R
Arm Type
Experimental
Arm Description
anti cancer agents
Intervention Type
Drug
Intervention Name(s)
Oshadi D and Oshadi R
Intervention Description
anti cancer agents
Primary Outcome Measure Information:
Title
Adverse events and serious adverse events occurence
Description
Adverse events and serious adverse events report
Time Frame
One month following treatment initiation
Secondary Outcome Measure Information:
Title
overall survival time
Description
Overall survival time from treatment initiation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hovav Nehushtan, Prof.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel

12. IPD Sharing Statement

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

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