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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Oshadi Drug Administration
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration
ClinicalTrials.gov Identifier:
NCT01627795
First received: June 20, 2012
Last updated: October 27, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Mesothelioma
Drug: Oshadi D and Oshadi R
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oshadi Drug Administration:

Primary Outcome Measures:
  • Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival time [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 17
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oshadi D and Oshadi R
anti cancer agents
Drug: Oshadi D and Oshadi R
anti cancer agents

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627795

Contacts
Contact: Hanna Levy, Dr. +972-52-2824966 hanna@oshadi-da.com

Locations
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 91240
Contact: Hovav Nehushtan, Prof.    +972-50-894-6057    hovavnech@hadassah.org.il   
Contact: Hanna Levy, Dr.    +972-52-282-4966    hanna@oshadi-da.com   
Principal Investigator: Hovav Nechushtan, Prof.         
Sponsors and Collaborators
Oshadi Drug Administration
Investigators
Principal Investigator: Hovav Nehushtan, Prof. Hadassah Medical Center
  More Information

No publications provided

Responsible Party: Oshadi Drug Administration
ClinicalTrials.gov Identifier: NCT01627795     History of Changes
Other Study ID Numbers: OS-MES-P2-01
Study First Received: June 20, 2012
Last Updated: October 27, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Oshadi Drug Administration:
Malignant Mesothelioma
Cancer
Anti cancer agents

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014