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Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

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ClinicalTrials.gov Identifier: NCT02965417
Recruitment Status : Withdrawn (Symphogen made a business decision to no longer perform the clinical study.)
First Posted : November 16, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Symphogen A/S

Brief Summary:
This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Sym004 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase 2 Trial Investigating Sym004 in Patients With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies and Documented Mutation of Extra Cellular Domain of EGFR (ECD-EGFR)
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Sym004
All patients will receive a loading dose of Sym004, followed by weekly (q1w) infusions
Drug: Sym004
Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).




Primary Outcome Measures :
  1. Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.
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Responsible Party: Symphogen A/S
ClinicalTrials.gov Identifier: NCT02965417    
Other Study ID Numbers: Sym004-11
2016-000621-39 ( EudraCT Number )
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Symphogen A/S:
Resistance to anti-EGFR monoclonal antibodies
Mutation of ECD-EGFR
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases