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Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer (FAST)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630083
First Posted: June 28, 2012
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
  Purpose

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.


Condition Intervention Phase
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction CLDN18.2-positive Adenocarcinoma of Esophagus CLDN18.2-positive Gastric Adenocarcinoma Drug: Epirubicin Drug: Oxaliplatin Drug: Capecitabine Drug: IMAB362 800/600 mg/m2 Drug: IMAB362 1000 mg/m2 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: at least 33 months ]
    PFS is defined as the time from randomization of therapy to the first observation of disease progression or death from any cause or last tumor evaluation if free of progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.

  • Safety and Tolerability [ Time Frame: at least 33 months ]
    Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.


Secondary Outcome Measures:
  • Survival rate at 12 months [ Time Frame: at least 33 months ]
    To determine survival status at 12 months following initiation of therapy each patient will be classified as alive or dead (irrespective of cause of death). For this purpose, upon completion of the last cycle, all patients will continue to be followed until death or loss to follow up. Patients who discontinue treatment due to progression will be followed in the same manner.

  • Overall survival (OS) [ Time Frame: at least 33 months ]
    Overall survival is defined as the time from randomization to death from any cause or last contact if alive.

  • Time to progression (TTP) [ Time Frame: at least 33 months ]
    TTP is defined as the time from randomization of therapy to the first observation of confirmed disease progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.

  • Objective tumor response rate (ORR) [ Time Frame: at least 33 months ]
    ORR comprises the fraction of patients with CR, PR according to RECIST v1.1. It is set in relation to the ITT population and PP population (see section 8).

  • Disease control rate (DCR) [ Time Frame: at least 33 months ]
    DCR is defined as the fraction of patients with CR or PR or SD according to RECIST v1.1. It is set in relation to the ITT population and PP population

  • Duration of response (DOR) [ Time Frame: at least 33 months ]
    Duration of response is determined as the time when criteria for CR, PR, and SD are first met until the first date that recurrent or progressive disease or death occurs.


Enrollment: 252
Actual Study Start Date: June 1, 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EOX
Participants will receive EOX.
Drug: Epirubicin
50 mg/m2; d 1 q3w for max. 8 cycles
Drug: Oxaliplatin
130 mg/m2; d 1 q3w for max. 8 cycles
Drug: Capecitabine
625 mg/m2; p.o. d 1 - d 21 q3w twice daily for max. 8 cycles
Experimental: EOX + IMAB362 800/600 mg/m2
Participants will receive EOX and IMAB362 (800 mg/m^2 loading dose in cycle 1 followed by 600 mg/m^2 every 3 weeks).
Drug: Epirubicin
50 mg/m2; d 1 q3w for max. 8 cycles
Drug: Oxaliplatin
130 mg/m2; d 1 q3w for max. 8 cycles
Drug: Capecitabine
625 mg/m2; p.o. d 1 - d 21 q3w twice daily for max. 8 cycles
Drug: IMAB362 800/600 mg/m2

800 mg/m2 loading dose on cycle 1.

600 mg/m2 every 3 weeks.

Experimental: EOX + IMAB362 1000 mg/m2
Participants will receive EOX and IMAB362 (1000 mg/m^2 every 3 weeks).
Drug: Epirubicin
50 mg/m2; d 1 q3w for max. 8 cycles
Drug: Oxaliplatin
130 mg/m2; d 1 q3w for max. 8 cycles
Drug: Capecitabine
625 mg/m2; p.o. d 1 - d 21 q3w twice daily for max. 8 cycles
Drug: IMAB362 1000 mg/m2
1000 mg/m2 every 3 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630083


  Show 53 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Executive Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01630083     History of Changes
Other Study ID Numbers: GM-IMAB-001-03
2011-005285-38 ( EudraCT Number )
First Submitted: June 19, 2012
First Posted: June 28, 2012
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Capecitabine
Oxaliplatin
Epirubicin
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs