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 2015 by Oshadi Drug Administration.
Recruitment status was: Recruiting
First Posted : May 9, 2014
Last Update Posted : April 22, 2015
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|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
|Experimental: Oshadi D and Oshadi R with Docetaxel||
Drug: Oshadi D and Oshadi R
Anti cancer agentsDrug: Docetaxel
Other Name: Taxoter
- overall survival time [ Time Frame: 12 months ]
- Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ]
- Patient report outcome [ Time Frame: 12 months ]To assess patients quality of life by QLC30 questionnaire
- Progression Free Survival (PFS - time from treatment initiation to documentation of disease progression or death); [ Time Frame: 12 months ]
- Duration of Response (DoR); [ Time Frame: 12 months ]
- Change in tumor size [ Time Frame: 12 weeks ]
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|