Spots Global Cancer Trial Database for Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas
Official Title: A Single-arm Multicentre Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Who Have Not Previously Received Therapy for Metastatic Adenocarcinoma of the Pancreas
Study ID: NCT06225999
Study Description
Brief Summary: This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. During the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. At least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. Study visits may include questionnaires, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chiba University Hospital (015), Chiba, , Japan
Chiba Cancer Center (011), Chiba, , Japan
National Hospital Organization Shikoku Cancer Center (013), Ehime, , Japan
National Hospital Organization Kyushu Cancer Center (005), Fukuoka, , Japan
Kanazawa University Hospital (008), Ishikawa, , Japan
JPN-003, Jpn-003, , Japan
Kanagawa Cancer Center (002), Kanagawa, , Japan
Aichi Cancer Center (007), Nagoya, , Japan
Osaka International Cancer Institute (009), Osaka, , Japan
Saitama Cancer Center (012), Saitama, , Japan
Hokkaido University Hospital (004), Sapporo, , Japan
National Cancer Center Hospital (001), Tokyo, , Japan
The Cancer Institute Hospital of JFCR (006), Tokyo, , Japan
Kyorin University Hospital (014), Tokyo, , Japan
Yamaguchi University Hospital (010), Yamaguchi, , Japan
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
