The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Inje University Haeundae Paik Hospital
Busan, South Korea
Kyungpook National University Medical Center
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Progression Free Survival
PFS is defined as the time From date of randomization until the date of first documented progression or death, assessed up to 24 months.
Time frame: Participants will be followed until progression, an expected average of 4 months.
Overall Survival
OS is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.
Time frame: Until 6 months after the last participant is enrolled, assessed up to 24 months.
Overall Response Rate
ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
Time frame: Participants will be followed every 6 weeks until progression, an expected average of 4 months.
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Chonnam National University Hwasun Hospital
Jungnam, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
...and 3 more locations