Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02134990|
Recruitment Status : Unknown
Verified April 2018 by Oshadi Drug Administration.
Recruitment status was: Recruiting
First Posted : May 9, 2014
Last Update Posted : April 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Oshadi D and Oshadi R Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Oshadi D and Oshadi R with Docetaxel
Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy
Drug: Oshadi D and Oshadi R
Anti cancer agents
Other Name: Taxoter
- overall survival time [ Time Frame: 12 months ]overall survival of the patient
- Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ]Adverse events and serious adverse events occurred during the study
- Patient report outcome [ Time Frame: 12 months ]To assess patients quality of life by QLC30 questionnaire
- Progression Free Survival (PFS) [ Time Frame: 12 months ]time from treatment initiation to documentation of disease progression or death)
- Duration of Response (DoR); [ Time Frame: 12 months ]response duration to the drug
- Change in tumor size [ Time Frame: 12 weeks ]changes in tumor size
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134990
|Contact: Hanna Levy, Dr.||+email@example.com|
|Hadassah Medical Center||Recruiting|
|Contact: Hanna Levy, Dr. +972-52-2824966 firstname.lastname@example.org|
|Principal Investigator: Hovav Nehushtan, Prof.|
|Principal Investigator:||Hovav Nehushtan, Prof.||Hadassah Medical Center|