Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHP107 (oral paclitaxel) | Experimental | DHP107 (oral paclitaxel) will be administered weekly as second line chemotherapy in patients with metastatic or recurrent gastric cancer after failure of first line chemotherapy with fluoropyrimidine +/- platinum. |
|
| Taxol® (IV paclitaxel) | Active Comparator | Taxol® (IV paclitaxel) will be administered 3-weekly as second line chemotherapy in patients with metastatic or recurrent gastric cancer after failure of first line chemotherapy with fluoropyrimidine +/- platinum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed until progression, an expected average of 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS is defined as the time from the date of inclusion to the date of death, regardless of the cause of death. | Until 6 months after the last participant is enrolled, assessed up to 24 months. |
| Overall Response Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Haeundae Paik Hospital | Busan | 612-896 | South Korea | |||
| Kyungpook National University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29438463 | Derived | Kang YK, Ryu MH, Park SH, Kim JG, Kim JW, Cho SH, Park YI, Park SR, Rha SY, Kang MJ, Cho JY, Kang SY, Roh SY, Ryoo BY, Nam BH, Jo YW, Yoon KE, Oh SC. Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy. Ann Oncol. 2018 May 1;29(5):1220-1226. doi: 10.1093/annonc/mdy055. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Paclitaxel | Drug | Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent |
|
|
ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
| Participants will be followed every 6 weeks until progression, an expected average of 4 months. |
| Daegu |
| 702-210 |
| South Korea |
| National Cancer Center | Goyang-si | 410-769 | South Korea |
| Chonnam National University Hwasun Hospital | Jungnam | 519-763 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Yonsei University Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | 138-736 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Ajou University Hospital | Suwon | 443-380 | South Korea |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided