Sym004 in Combitation with FOLFIRI (chemotherapy regimen) in metastatic colorectal cancer

Phase 1

• Conditions: Patients with locally advanced or metastatic CRC, wild type KRAS/NRAS (exon 2, 3, 4) will be enrolled.; MedDRA version: 18.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003047-19-ES
• Lead Sponsor: Symphogen A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

?Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
?Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
or
Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
*Failure is defined as radiologic progression

?Eligible for FOLFIRI
?Measurable disease according to RECIST v1.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

?Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
?Any antineoplastic agent (standard or investigational) within 4 weeks prior to first administration of trial treatments
?Significant gastrointestinal abnormalities, as per defined criteria
?Significant cardiovascular disease, as per defined criteria
?Abnormal hematologic, renal or hepatic function, as per defined criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified