Pharmacokinetic and Pharmacodynamic study of nab-Paclitaxel and solvent-based Paclitaxel in patients with metastatic or recurrent gastric cancer

Pharmacokinetic and Pharmacodynamic study of nab-Paclitaxel and solvent-based Paclitaxel in patients with metastatic or recurrent gastric cancer - PK/PD study of nab-PTX and solvent-based PTX in metastatic GC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030277

Enrollment

Registered

2017-12-05

Start date

2017-12-12

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 or recurrent gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Gastric or esophagogastric cancer 2) Histologically proven adenocarcinoma or special type (carcinoid tumor and endocrine carcinoma are excluded) 3) Metastatic or recurrent disease 4) ECOG PS 0-2 5) Refractory or intolerant to fluoropyrimidine

Exclusion criteria

Exclusion criteria: 1) Active infection 2) Women who is pregnant, suspected of being pregnant, within 28 days of postparturition, or lactating 3) Coexisting psychiatric disease 4) Continuous use of immune-suppressive agent 5) Known hypersensitivity to paclitaxel or albumin compound

Design outcomes

Primary

Measure	Time frame
Concentration of unbound paclitaxel and neutrophil count during 28 days from the commencement of nab-paclitaxel or solvent-based paclitaxel administration	—

Countries

Japan

Contacts

Public ContactTakahiro Tsushima

Shizuoka Cancer Center Division of Gastrointestinal Oncology

t.tsushima@scchr.jp055-989-5222

Outcome results