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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.
 
ClinicalTrials.gov Identifier: NCT01627795
Recruitment Status : Suspended
First Posted : June 26, 2012
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE June 26, 2012
Last Update Posted Date April 18, 2018
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ]
Adverse events and serious adverse events report
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
overall survival time [ Time Frame: 12 months ]
Overall survival time from treatment initiation
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2012)
overall survival time [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mesothelioma
Intervention  ICMJE Drug: Oshadi D and Oshadi R
anti cancer agents
Study Arms  ICMJE Experimental: Oshadi D and Oshadi R
anti cancer agents
Intervention: Drug: Oshadi D and Oshadi R
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 25, 2012)
17
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01627795
Other Study ID Numbers  ICMJE OS-MES-P2-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oshadi Drug Administration
Study Sponsor  ICMJE Oshadi Drug Administration
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hovav Nehushtan, Prof. Hadassah Medical Center
PRS Account Oshadi Drug Administration
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP