Overview

This trial is active, not recruiting.

Conditions cldn18.2-positive gastric adenocarcinoma, cldn18.2-positive adenocarcinoma of esophagus, cldn18.2-positive adenocarcinoma of the gastroesophageal junction
Treatments epirubicin, oxaliplatin, capecitabine, imab362 800/600 mg/m2, imab362 1000 mg/m2
Phase phase 2
Sponsor Ganymed Pharmaceuticals AG
Start date June 2012
End date September 2018
Trial size 252 participants
Trial identifier NCT01630083, 2011-005285-38, GM-IMAB-001-03

Summary

The purpose of the trial is to assess the therapeutic effects and the safety profile of IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for patients with advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction compared to EOX alone.

Furthermore, sufficient binding of IMAB362 to the target cells is necessary for antitumoral activity. Thus, two dose levels ensuring a serum level above the in vitro predicted clinical efficacy threshold will be investigated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
epirubicin
50 mg/m2; d 1 q3w for max. 8 cycles
oxaliplatin
130 mg/m2; d 1 q3w for max. 8 cycles
capecitabine
625 mg/m2; p.o. d 1 - d 21 q3w twice daily for max. 8 cycles
(Experimental)
epirubicin
50 mg/m2; d 1 q3w for max. 8 cycles
oxaliplatin
130 mg/m2; d 1 q3w for max. 8 cycles
capecitabine
625 mg/m2; p.o. d 1 - d 21 q3w twice daily for max. 8 cycles
imab362 800/600 mg/m2
800 mg/m2 loading dose on cycle 1. 600 mg/m2 every 3 weeks.
(Experimental)
epirubicin
50 mg/m2; d 1 q3w for max. 8 cycles
oxaliplatin
130 mg/m2; d 1 q3w for max. 8 cycles
capecitabine
625 mg/m2; p.o. d 1 - d 21 q3w twice daily for max. 8 cycles
imab362 1000 mg/m2
1000 mg/m2 every 3 weeks.

Primary Outcomes

Measure
Progression-free survival (PFS)
time frame: at least 33 months
Safety and Tolerability
time frame: at least 33 months

Secondary Outcomes

Measure
Survival rate at 12 months
time frame: at least 33 months
Overall survival (OS)
time frame: at least 33 months
Time to progression (TTP)
time frame: at least 33 months
Objective tumor response rate (ORR)
time frame: at least 33 months
Disease control rate (DCR)
time frame: at least 33 months
Duration of response (DOR)
time frame: at least 33 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction - Inoperable locally advanced disease or resections with R2 outcome or recurrent or metastatic disease. - CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample. - Measurable and/or non-measurable disease as defined according to RECISTv1.1 - Age ≥ 18 years - Written Informed Consent Form - ECOG performance status (PS) 0-1 - Life expectancy > 3 months - HER2/neu negative patients and patients with HER2/neu positive status but not eligible to trastuzumab therapy in discretion of the investigator. - Adequate cardiac, hepatic, renal, hematologic function. Exclusion Criteria: - Prior severe allergic reaction or intolerance to a monoclonal antibody, to the chemotherapeutics used in this study or any excipient in the respective formulations. - Previous chemotherapy for advanced disease. - Previous perioperative chemotherapy with curative intention within 6 months of start of study treatment. If interval is longer than 6 months (counted from the stop date of the perioperative chemotherapy), patients are allowed. - Known HIV infection or known symptomatic hepatitis (A, B, C). - Symptomatic cerebral metastases. - Pregnancy or breastfeeding. - Previous treatments with maximum cumulative doses of epirubicin > 500 mg/m² and/or other anthracyclines and anthracenediones. - Known dihydropyrimidine dehydrogenase (DPD) deficiency.

Additional Information

Official title A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX Regimen as First-Line Treatment of Patients With CLDN18.2-positive Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction.
Principal investigator Martin Schuler, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Ganymed Pharmaceuticals AG.