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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


Phase 1/Phase 2
21 Years
N/A
Not Enrolling
Both
Mesothelioma

Thank you

Trial Information

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


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 and alkaline phosphatase must be < 1.5 times
of the upper limit of normal.

- LDH < 500 int. unit/L

- Estimated GFR > 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 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 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events and serious adverse events occurence

Outcome Time Frame:

One month following treatment initiation

Safety Issue:

Yes

Principal Investigator

Hovav Nehushtan, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Center

Authority:

Israel: Ethics Commission

Study ID:

OS-MES-P2-01

NCT ID:

NCT01627795

Start Date:

July 2013

Completion Date:

December 2015

Related Keywords:

  • Mesothelioma
  • Malignant Mesothelioma
  • Cancer
  • Anti cancer agents
  • Mesothelioma

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