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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01627795
Recruitment Status : Suspended
First Posted : June 26, 2012
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Oshadi Drug Administration

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.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Oshadi D and Oshadi R Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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 Start Date : December 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Oshadi D and Oshadi R
anti cancer agents
Drug: Oshadi D and Oshadi R
anti cancer agents

Primary Outcome Measures :
  1. Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ]
    Adverse events and serious adverse events report

Secondary Outcome Measures :
  1. overall survival time [ Time Frame: 12 months ]
    Overall survival time from treatment initiation

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01627795

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Hadassah Medical Center
Jerusalem, Israel, 91240
Sponsors and Collaborators
Oshadi Drug Administration
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Principal Investigator: Hovav Nehushtan, Prof. Hadassah Medical Center
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Responsible Party: Oshadi Drug Administration Identifier: NCT01627795    
Other Study ID Numbers: OS-MES-P2-01
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Oshadi Drug Administration:
Malignant Mesothelioma
Anti cancer agents
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial