Trial Title:
Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas
NCT ID:
NCT06225999
Condition:
Metastatic Adenocarcinoma of the Pancreas
Conditions: Official terms:
Adenocarcinoma
Leucovorin
Oxaliplatin
Fluorouracil
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan liposome injection (S095013)
Description:
Irinotecan liposome injection (S095013) will be administered via intravenous (IV)
infusion on days 1 and 15 of each 28-day cycle.
Arm group label:
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
Other name:
MM-398
Other name:
Nal-IRI
Other name:
BAX2398
Other name:
PEP02
Other name:
liposomal irinotecan
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each
28-day cycle.
Arm group label:
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
Intervention type:
Drug
Intervention name:
LLV (levoisomer form of leucovorin)
Description:
LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day
cycle.
Arm group label:
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
Intervention type:
Drug
Intervention name:
5- FU (5-Fluorouracil)
Description:
5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day
cycle.
Arm group label:
Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or non-pregnant and non-lactating female ≥ 18 years of age.
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that has
not been previously treated in the metastatic setting.
- Initial diagnosis of metastatic disease (as per American Joint Committee on Cancer
8th Edition [AJCC 2017]) must have occurred ≤ 6 weeks prior to screening.
- Participant has one or more metastatic lesions measurable by CT-scan (or MRI), if
the participant is allergic to CT contrast media, according to RECIST Version 1.1
criteria.
- ECOG PS of 0 or 1 at screening and within 7 days prior to first dosing.
- Participant has adequate hematological, biochemical, hepatic, and renal function
parameters.
Exclusion Criteria:
- Prior treatment of pancreatic cancer in the metastatic setting with surgery,
radiotherapy, chemotherapy or investigational therapy (palliative surgery,
palliative radiotherapy and placement of biliary stent/tube are permitted).
- Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant
setting, except those where at least 12 months have elapsed since completion of the
last dose and no persistent treatment-related relevant toxicities are present.
- Participant has only locally advanced disease.
- Known hypersensitivity to any of the components of irinotecan liposome injection,
other liposomal products, or any components of 5-FU, LLV or oxaliplatin products.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East (003)
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Facility:
Name:
Chiba University Hospital (015)
Address:
City:
Chiba
Zip:
260-8677
Country:
Japan
Facility:
Name:
Chiba Cancer Center (011)
Address:
City:
Chiba
Zip:
260-8717
Country:
Japan
Facility:
Name:
National Hospital Organization Shikoku Cancer Center (013)
Address:
City:
Ehime
Zip:
791-0280
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Cancer Center (005)
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Facility:
Name:
Kanazawa University Hospital (008)
Address:
City:
Ishikawa
Zip:
920-8641
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center (002)
Address:
City:
Kanagawa
Zip:
241-8515
Country:
Japan
Facility:
Name:
Aichi Cancer Center (007)
Address:
City:
Nagoya
Zip:
464-8681
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute (009)
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Facility:
Name:
Saitama Cancer Center (012)
Address:
City:
Saitama
Zip:
362-0806
Country:
Japan
Facility:
Name:
Hokkaido University Hospital (004)
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Facility:
Name:
National Cancer Center Hospital (001)
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR (006)
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Facility:
Name:
Yamaguchi University Hospital (010)
Address:
City:
Yamaguchi
Zip:
755-8505
Country:
Japan
Start date:
April 25, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Institut de Recherches Internationales Servier
Agency class:
Other
Source:
Servier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06225999
