Clinical Trials /

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

NCT02083653

Description:

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Sym004</span> vs <span class="go-doc-concept go-doc-intervention">Standard of Care</span> in Subjects With Metastatic <span class="go-doc-concept go-doc-disease">Colorectal Cancer</span>

Title

  • Brief Title: Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer
  • Official Title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator`s Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies
  • Clinical Trial IDs

    NCT ID: NCT02083653

    ORG ID: EMR200637-002

    NCI ID: 2013-003829-29

    Trial Conditions

    Metastatic Colorectal Cancer

    Trial Interventions

    Drug Synonyms Arms
    Sym004 Arm A: Sym004
    Sym004 Arm B: Sym004
    Fluorouracil (5-FU) Arm C: Investigator's choice
    Capecitabine Arm C: Investigator's choice

    Trial Purpose

    This is a Phase 2, open-label, 3-arm trial of two Sym004 doses (Arms A and B) and a control
    group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance
    to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A: Sym004 Experimental Sym004
    Arm B: Sym004 Experimental Sym004
    Arm C: Investigator's choice Active Comparator Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion. Fluorouracil (5-FU), Capecitabine

    Eligibility Criteria

    Inclusion Criteria:

    - Written informed consent obtained before undergoing any study-related activities

    - Male or female, at least 18 years of age

    - Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma
    wild-type (KRAS WT) at initial diagnosis

    - Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan

    - Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol

    - Measurable disease defined as one or more target lesions according to RECIST

    - Life expectancy of at least 3 months

    - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1

    - Other protocol defined inclusion criteria could apply

    Exclusion Criteria:

    - Pretreatment with regorafenib.

    - Subjects who in the opinion of the subject and investigator would benefit more
    from regorafenib treatment (except where regorafenib is not reimbursed in the
    country)

    - Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from
    previous anti-EGFR therapy at time of randomization

    - Magnesium less than 0.9 milligram per deciliter (mg/dL)

    - Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4
    infusion related reactions with anti-EGFR mABs

    - Other protocol defined exclusion criteria could apply

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall survival (OS) Time

    Secondary Outcome Measures

    Best overall response according to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

    Progression Free Survival (PFS) Time

    Time to treatment failure

    Relative dose intensity of Sym004

    Pharmacokinetic parameters: AUC (0-168 hours), t1/2, CL, Vd, Cmax, tmax and C(trough)

    Host immune response: Number of subjects with anti-drug antibodies (ADAs)

    Biomarkers level related to the Epidermal growth factor receptor (EGFR) pathway

    Quality of life assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 30 (EORTC QLQ-C30) (Version 3)

    Quality of life assessed by EORTC QLQ module for colorectal cancer (EORTC QLQ-CR29)

    Quality of life assessed by Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFR 18)

    Number of subjects with adverse events (AEs), serious AEs, treatment emergent AEs, AEs leading to death, and AEs with National Cancer Institute-Common Terminology Criteria for AEs (NCICTCAE Version 4.03) Grade greater than or equal to 3

    Trial Keywords

    Metastatic Colorectal Cancer

    Sym004

    Best Supportive Care

    Capecitabine

    Fluorouracil (5-FU)