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Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer.

NCT03688230 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-03-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.

Conditions

Interventions

DRUG

abituzumab

1000 mg IV

COMBINATION_PRODUCT

Placebo + Cetuximab + FOLFIRI

400 mg/m2 over 120 min followed by 250 mg/m2 weekly 60 min or 500 mg/m2 every two weeks, initially 120 min followed by 60 to 90 min

Sponsors & Collaborators

  • SFJ Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    collaborator OTHER

  • Academic and Community Cancer Research United

    collaborator OTHER

  • SFJ Pharmaceuticals X, LTD.

    lead INDUSTRY

Principal Investigators

  • Dirk Arnold, Prof. Dr. · Asklepios Tumorzentrum Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-12-31
Completion
2021-08-31
FDA Drug
Yes

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Entities

Diseases

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 NCT03688230 on ClinicalTrials.gov