Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Oshadi D and Oshadi R
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oshadi D and Oshadi R with Docetaxel<br>Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy | Drug: Oshadi D and Oshadi R<br>* Anti cancer agents<br>Drug: Docetaxel<br>* Chemotheraphy<br>* Other names: Taxoter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival time | overall survival of the patient | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non-Small-Cell Lung, Docetaxel