Randomized phase II study of NaliCap (nal-IRI/Capecitabine) compared to NAPOLI (nal-IRI/5-FU/LV) in Gemcitabine-pretreated advanced pancreatic cancer

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0004845

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1)Signed informed consent
2)Age>20 years at time of study entry
3)Histologically confirmed pancreatic ductal adenocarcinoma
4)Advanced stage (unresectable, recurrent)
5)Gemcitabine-pretreated for advanced pancreatic cancer
6)ECOG 0, 1
7)Adequate organ function
?-Haemoglobin = 9.0 g/dL
?-Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)
?-Platelet count = 100 (or 75) x 109/L (>75,000 per mm3)
?-Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
?-AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be = 5x ULN
?-Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
8)Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects.
9)Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria

1)Participation in another clinical study with an investigational product during the last 3 weeks
2)Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
3)Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
4)Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
5)Known brain metastasis or spinal cord compression.
6)History of allogenic organ transplantation
7)Cardiac event during past 6 months
8)Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
9)Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
10)Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of IP.
11)Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
12)Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.