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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oshadi D and Oshadi R with Docetaxel | Experimental | Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oshadi D and Oshadi R | Drug | Anti cancer agents |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival time | overall survival of the patient | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events occurence | Adverse events and serious adverse events occurred during the study | One month following treatment initiation |
| Patient report outcome | To assess patients quality of life by QLC30 questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | time from treatment initiation to documentation of disease progression or death) | 12 months |
| Duration of Response (DoR); | response duration to the drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Levy, Dr. | Contact | +972-52-2824966 | hanna@oshadi-da.com |
| Name | Affiliation | Role |
|---|---|---|
| Hovav Nehushtan, Prof. | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel |
| Drug |
Chemotheraphy |
|
|
| 12 months |
| 12 months |
| Change in tumor size | changes in tumor size | 12 weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |