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

NCT01627795 | Suspended Phase 1

• 1 other identifier: OS-MES-P2-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesothelioma

Keywords

Malignant Mesothelioma; Cancer; Anti cancer agents

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events occurence

  Adverse events and serious adverse events report

  One month following treatment initiation

Secondary Outcomes (1)

• overall survival time

  12 months

Study Arms (1)

Oshadi D and Oshadi R

EXPERIMENTAL

anti cancer agents

Drug: Oshadi D and Oshadi R

Interventions

Oshadi D and Oshadi R DRUG

anti cancer agents

Oshadi D and Oshadi R

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oshadi Drug Administration: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91240, Israel

Location

MeSH Terms

Conditions

Mesothelioma; Mesothelioma, Malignant; Neoplasms

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hovav Nehushtan, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 26, 2012
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

IL (1)