Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01201018
Status:
COMPLETED
Last Update Posted:
2012-06-21
First Post:
2010-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
Sponsor:
Oshadi Drug Administration
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: