A Study of Oraxol® in Gastric Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01491217|
Recruitment Status : Unknown
Verified December 2011 by Hanmi Pharmaceutical Company Limited.
Recruitment status was: Recruiting
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Advanced Metastatic Gastric Cancer Recurrent Gastric Cancer||Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||December 2012|
- Toxicity evaluation (safety evaluation) [ Time Frame: DLT will be assessed on 28days of 1 cycle ]Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).
- Overall response rate(ORR) evaluation [ Time Frame: Response will be evaluated every Cycle 2(8weeks) ]
It is measured up to confirmation of tumor response(CR, PR)
Tumor response will be evaluated by RECIST v1.0.
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): NCT01491217
|Contact: Kyung-Mi Park, Ph.Dfirstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang, Korea, Republic of|
|Contact: Sook Ryun Park, M.D, Ph.D|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Yung-Jue Bang, M.D, Ph.D|
|Principal Investigator:||Yung-Jue Bang, MD. Ph.D||Seoul National University Hospital|