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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

NCT02862535 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-12-24

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-20
Primary Completion
2019-10-25
Completion
2019-10-25
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02862535 on ClinicalTrials.gov