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Clinical trial

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

NCT03504397 is registered in ClinicalTrials.gov with Astellas Pharma Global Development, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Lead sponsor
Astellas Pharma Global Development, Inc.
Phase
Phase 3
Overall status
Active, not recruiting
Start date
June 21, 2018
Completion date
September 30, 2026
Enrollment
565 (actual)
Sites
220

Conditions

As the registry lists them; a condition with its own page is linked.

locally advanced unresectable gastric adenocarcinoma or cancer, locally advanced unresectable gastroesophageal junction (gej) adenocarcinoma or cancer, metastatic gastric adenocarcinoma or cancer, metastatic gastroesophageal junction (gej) adenocarcinoma