Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients

Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients - GENESECT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012720

Enrollment

250

Registered

2014-01-01

Start date

2014-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who confirmed the diagnosis of pancreatic cancer 2) Metastatic pancreatic cancer 3) 20 years of age or older 4) ECOG PS 0-2 5) No prior chemotherapy or radiotherapy before enrollment 6) Patients who scheduled for the standard dose of gemcitabine monotherapy or combination therapy with nab-Paclitaxel and gemcitabine as first line treatment 7)Patients with a serum CA19-9 level of >= 100 U/mL within 4 weeks prior to registration 8) Adequate organ function obtained within 4 weeks prior to registration. Laboratory values must be as follows; Absolute neutrophil count >= 1,500 /mm3, Hemoglobin >= 9.0 g/dL Platelet count >= 100,000 /mm3 AST <= 150 IU/L ALT <= 150 IU/L Total bilirubin less than or equal to 2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice) serum creatinine <= 1.5 mg/dL 9)Informed consent by the document

Exclusion criteria

Exclusion criteria: 1) Known prior severe hypersensitivity to clinical trial medicines 2)Patients with an active concomitantly existed 3)Patients with an active concomitant infection 4)Patients with pulmonary fibrosis or interstitial pneumonia 5)Patient with severe uncontrollable diabetes mellitus 6)Pregnant, breastfeeding or expecting woman 7)Other clinical difficulties in this study

Design outcomes

Primary

Measure	Time frame
CA19-9 response: Reduction of >50% from the pretreatment level at 8 weeks after first gemcitabine administration.	—

Secondary

Measure	Time frame
1) Time to CA19-9 response during gemcitabine treatment 2) The proportion of CA19-9 decrease in the pre-treatment level and nadir level. 3) Overall survival 4) Adverse drug reactions	—

Countries

Japan

Contacts

Public ContactDaiki TSUJI

Univercity of Shizuoka School of Pharmaceutical Science

d-tsuji@u-shizuoka-ken.ac.jp054-264-5674

Outcome results