MesotheliomaPhase 1/2NCT01627795
Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment
A Phase 1/2 study testing Oshadi D and Oshadi R in people with Mesothelioma, run by Oshadi Drug Administration at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Oshadi D and Oshadi R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2016to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Oshadi D and Oshadi R
- Keywords
- Malignant Mesothelioma, Cancer, Anti cancer agents
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oshadi D and Oshadi RDrug
anti cancer agents
| Study group | Role | What they receive |
|---|---|---|
| Oshadi D and Oshadi R | Experimental | anti cancer agents Receives: Drug: Oshadi D and Oshadi R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and serious adverse events occurence
Adverse events and serious adverse events report
Measured: One month following treatment initiation
Secondary outcomes (1)
overall survival time
Overall survival time from treatment initiation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startDec 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oshadi Drug Administration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hovav Nehushtan, Prof., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627795
- Sponsor's protocol ID
- OS-MES-P2-01
- Status last verified
- Apr 2018
- First submitted
- 20 Jun 2012
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01627795
- Acronym / sponsor ID
- OS-MES-P2-01
- Conditions
- Mesothelioma
- Keywords
- Malignant Mesothelioma, Cancer, Anti cancer agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oshadi D and Oshadi R | Experimental | Drug: Oshadi D and Oshadi Ranti cancer agents |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Written informed consent
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oshadi D and Oshadi Ranti cancer agents | Drug | Oshadi D and Oshadi R |
Primary outcome
Adverse events and serious adverse events occurence
Time frame: One month following treatment initiation
Adverse events and serious adverse events report
1 secondary outcome
overall survival time
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
Related trials for Mesothelioma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hovav Nehushtan, Prof. principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oshadi D and Oshadi R in people with Mesothelioma, run by Oshadi Drug Administration at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events occurence (time frame: One month following treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.