Study on Umorestat Hydrogen Sulfate Capsule in Patients With Locally Advanced/Metastatic Pancreatic Cancer

Sun Yat-sen University

Status: Unknown

Conditions: Gene Polymorphisms; Pancreatic Cancer; Pharmacokinetics

Treatments: Genetic: Genotyping

Study type: Observational

Funder types: Other

Identifiers

NCT05329597

2020-KY-040

Details and patient eligibility

About

Based on the tolerability, safety and pharmacokinetics phase I/II clinical trials of ulimostat hydrochloride capsules (LH011) combined with gemcitabine hydrochloride (GEM) in locally advanced/metastatic pancreatic cancer patients, to determine pharmacokinetics, the biotransformation pathway and metabolite profile of ulimostat in patients with locally advanced/metastatic pancreatic cancer.

Full description

This study is a research on the pharmacokinetics and gene polymorphisms of ulimostat hydrochloride capsules in patients with locally advanced/metastatic pancreatic cancer. Aims to collect the "Phase I/II clinical trials of the tolerability, safety and pharmacokinetics of ulimostat capsules (LH011) combined with gemcitabine hydrochloride (GEM) in patients with locally advanced/metastatic pancreatic cancer" patient's peripheral blood sample to determine the structure of the metabolites of ulimostat in the biological samples and trough concentration and genotyping tests were performed on patients to investigate the correlation between gene polymorphisms of metabolic enzymes, transporters, target protein uPA and proteins expressed in upstream and downstream signaling pathways and blood drug concentration, efficacy, safety and tolerance of ulimostat.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully enrolled in a Phase I/II clinical study on the tolerability, safety and pharmacokinetics of Umorestat hydrogen Sulfate capsule (LH011) combined with gemcitabine hydrochloride (GEM) for patients with locally advanced/metastatic pancreatic cancer.
• Fully understand the purpose and requirements of this study and sign a written informed consent.
• Willing to provide blood samples.

Exclusion criteria

• Suffering from inflammatory bowel disease.
• The researcher considers it unsuitable to participate in this study.

Trial design

88 participants in 4 patient groups

100mg

Description:

After 15 consecutive days of takeing 100mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

Treatment:

Genetic: Genotyping

200mg

Description:

After 15 consecutive days of takeing 200mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

Treatment:

Genetic: Genotyping

400mg

Description:

After 15 consecutive days of takeing 400mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

Treatment:

Genetic: Genotyping

600mg

Description:

After 15 consecutive days of takeing 600mg Umorestat capsule of each participant, 2 mL of peripheral venous blood is collected at 3 h, 8 h and 24 h (D16) on the 15th day into the vacuum blood collection tube via EDTA anticoagulation for genotyping and metabolite determination.

Treatment:

Genetic: Genotyping