Status and phase
Conditions
Treatments
About
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
Full description
The study includes dose-limiting toxicity (DLT)observing period and randomization period with two cohorts as low-dose group(Gentuximab Injection 8mg/kg+ paclitaxel) and high-dose group(Gentuximab Injection 12mg/kg+ paclitaxel). During the study,the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients. DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period. PK were doing in part of subjects.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
76 participants in 2 patient groups
Loading...
Central trial contact
Jin Li; Siqin Wang
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal