Carcinoma, Non-Small-Cell LungPhase 2NCT02134990
Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
A Phase 2 study testing Oshadi D and Oshadi R and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Oshadi Drug Administration at 1 site in Israel.
Trial summary
The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Oshadi D and Oshadi R and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to Jun 2019
- Phase
- Phase 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
- Locally advanced or metastatic NSCLC (IIIB-IV)
- Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
- Man or woman 21 years and above
- Adequate performance status (ECOG 0, and 1)
- Patient must have adequate organ function
- 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
- Any treatment with investigational agent within 10 days prior to registration for protocol therapy.
- Cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months prior to registration for protocol therapy.
- Evidence of pulmonary embolism within 3 months prior to registration for protocol therapy.
- Any history of hematologic malignancies.
- Patient with known 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.
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- Uncontrolled hypertension (>160/100 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 mal absorption 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.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Hanna Levy, Dr., +972-52-2824966, hanna@oshadi-da.com
Hovav Nehushtan, Prof.
About this study
Official title: A Phase IIa, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated.
Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.
CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3 Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be considered or subsequent therapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Oshadi D and Oshadi R, Docetaxel
- Keywords
- Carcinoma, Non-Small-Cell Lung, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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
DocetaxelDrug
Also called Taxoter
Chemotheraphy
| Study group | Role | What they receive |
|---|---|---|
| Oshadi D and Oshadi R with Docetaxel | Experimental | Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy Receives: Drug: Oshadi D and Oshadi R; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival time
overall survival of the patient
Measured: 12 months
Secondary outcomes (2)
Adverse events and serious adverse events occurence
Adverse events and serious adverse events occurred during the study
Measured: One month following treatment initiation
Patient report outcome
To assess patients quality of life by QLC30 questionnaire
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 posted9 May 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02134990
- Sponsor's protocol ID
- OS-LC-P2a-01
- Status last verified
- Apr 2018
- First submitted
- 7 May 2014
- 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 Phase IIa, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02134990
- Acronym / sponsor ID
- OS-LC-P2a-01
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 May 2014 (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.
The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated.
Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.
CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3 Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be considered or subsequent therapy.
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 with Docetaxel | Experimental | Drug: Oshadi D and Oshadi R, Drug: DocetaxelOshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Locally advanced or metastatic NSCLC (IIIB-IV)
- Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
- Man or woman 21 years and above
- Adequate performance status (ECOG 0, and 1)
- Patient must have adequate organ function
Key exclusion criteria (16 listed)
- Any treatment with investigational agent within 10 days prior to registration for protocol therapy.
- Cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months prior to registration for protocol therapy.
- Evidence of pulmonary embolism within 3 months prior to registration for protocol therapy.
- Any history of hematologic malignancies.
- Patient with known positive HIV serology at screening.
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 with Docetaxel |
| DocetaxelAlso: TaxoterChemotheraphy | Drug | Oshadi D and Oshadi R with Docetaxel |
Primary outcome
overall survival time
Time frame: 12 months
overall survival of the patient
2 secondary outcomes
Adverse events and serious adverse events occurence
Time frame: One month following treatment initiation
Patient report outcome
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.
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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 2 study testing Oshadi D and Oshadi R and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, 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 8 inclusion and 16 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: status not confirmed, 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 phase mean?
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?
Contact Hanna Levy, Dr. (+972-52-2824966, hanna@oshadi-da.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival time (time frame: 12 months). 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.