Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
The study will be non randomized, open label, dose rising study in cancer patients. Cancer treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered orally.
The study will include two sessions:
- A single dose period to evaluate acute toxicity of each drug
- Consecutive multiple increment dose escalation period of both drugs to determine the long-term safety, and the anticancer activity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment - A Phase I Study|
- Adverse events, serious adverse events occurrence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|