Phoenix study

JRCT ID: jRCTs031210040

Registered date:15/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic or recurrent pancreatic cancer
• Date of first enrollment: 14/05/2021
• Target sample size: 68
• Study type: Interventional

Intervention(s)

Patients continue to receive treatment according to a 14-day cycle unless the dicsontinuation criteria
are met.
Nanoliposomal irinotecan : intravenous infusion of over 90 min.
S-1 : Oral administration twice aday for consecutive 7 days
Phase 1 part:
Nanoliposomal irinotecan, 50~70mg/m2
S-1, 60~120mg/m2
Phase 2 part :
Phase 2 part will be initiated after recommended dose has been determined in Phase 2 part.

Outcome(s)

Primary Outcome

Phase 1 part : frequency of dose-limiting toxicities (DLTs)
Phase 2 part : overall survival

Secondary Outcome

Phase 1 part : frequency of other adverse events
Phase 2 part : objective response rate, progression-free survival,
disease control rate, frequency of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Histologically or cytologically confirmed adenocarcinoma;
(2) Metastatic or recurrent* pancreatic cancer diagnosed by contrast-enhanced CT(chest,abdomen,and pelvis) and / or MRI(abdomen and pelvis) imaging;
*If the patient received adjuvant chemotherapy and the diasese recurred within 6 manths after the completion,the patient is excluded from this study.
(3) Age of 20-80 years at time of enrollment;
(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
(5) Metastatic of recurrent pancreatic cancer refractory to first-line gemcitabin-based chemotherapy;
(6) Recovery of any toxicities by prior treatment except alopecia to grade 1 or less;
(7) Adequate oral intake;
(8) Adequate hematologic and organ function defined by the following laboratory test results,obtained within 7days prior to study enrollment;
1) Absolute neutrophil count (ANC) >- 1,500/mm3,
2) Hemoglobin >- 9.0g/dL,
3) Platelet count >- 100,000/mm3,
4) Serum total bilirubin <- 2.0mg/dL,
5) Aspartate transaminase (AST) <- 2.5 x upper limit of normal (ULN) without liver metastases (<-5 x ULN is acceptable if liver metastases are present),
6) Alanine transminase (ALT) <-2.5 x ULN without liver metastases (<-5 x ULN is acceptable if liver metastases are present).
7) Serum albmin >-3.0 g/ dL,
8) Creatinine clearance (CCr) >-50mL/min
(9) Signed written informed concsent form

Exclude criteria

(1) Prior exposure to irinotecan or fluropyrimidine*;
*Ajuvant chemotherapy with irinotecan and/or fluorouracil is permitted.
(2) History of malignancy (except for adequately treated carcinoma in situ, non-invasive cancer) within 2 years prior to study entry except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years;
(3) Evidence of uncontrolled,active infection,requiring anti-infectious treatment,except for viral hepatitis;
(4) Any chemotherapy for pancreatic cancer within 14days prior to the initiation of study treatment;
(5) Any major surgery*,radiotherapy, immunotherapy,or investigational drugs within 28 days prior to the initiation of study treatment;*In cases with exploratory laparotomy,intestinal bypass surgery,billiary bypass surgery ,or endoscopic resection, study entry is permitted if 14 days have passed.
(6) Suspected or known central nervous system (CNS) metastases (imaging required only if participants are symptomatic);
(7) Symptomatic ascites or pleural effusion;
(8) Significant lung disease,including interstitial lung disease,pulmonary fibrosis,or severe emphysema;
(9) Active watery diarrhea;
(10) Pregnant, lactating or females of childbearing age unless using highly effective contraception;
(11) Male with partner of child-bearing potential unless using highly effective contraception;
(12) Patients with significant psychiatric disorder;
(13) Significant comorbidities,such as uncontrolled diabetes mellitus, uncontrolled hypertension, New York Heart Association (NYHA) Class III or greater cardiac disease, chronic kidney disease, or liver dysfunction;
(14) Treatment with the following medications:
1) Systemic immunosuppressive medication, including corticosteroids, and immunosuppressant,
2) Flucytosine,
3) Phenytoin,
4) Warfarin,
5) Rifampicin,
6) Atazanavir sulfate,
(15) History of hypersensitivity to the following agents:
1) Irinotecan,
2) Fluoropyrimidines,
3) Any of the components/excipients of nanoliposomal-irinotecan (nal-IRI) and S1, or other liposomal products,
(16) Cannnot stop medications that are potent CYP3A4 inducers within 2 weeks and inhibitors within 1 week before start of study treatment.
(17) Patients whose entry in the study is considered by the investigator to be inappropriate;
(18) History of arterial thromboembolism (e.g., myocardial infarction, unstable angina,and cerebral
infarction) within 6 months prior to the initiation of study treatment,
(19) Presence of a UGT1A1 genetic polymorphism (UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 ;
phase 1 only)

Related Information

• Primary Sponsor: Ikeda Masafumi
• Source(s) of Monetary Support: Nihon Servier Co.,Ltd.