NCT02862535

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 1b Study to Evaluate the Safety and Tolerability of Andecaliximab (GS-5745) as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Subjects With Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to characterize the safety and tolerability of andecaliximab as monotherapy and in combination with anti-cancer agents in Japanese participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Andecaliximab	Administered via intravenous (IV) infusion (approximately 30 minutes)
DRUG	S-1	Administered orally
DRUG	Cisplatin	Administered via IV infusion on Day 8 of every 5 weeks
DRUG	Oxaliplatin	Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle
DRUG	Nivolumab	Administered via IV infusion (approximately 60 minutes) every 2 weeks

Timeline

• Start date: 2016-09-20
• Primary completion: 2019-10-25
• Completion: 2019-10-25
• First posted: 2016-08-11
• Last updated: 2020-12-24
• Results posted: 2020-12-24

Locations

3 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study