Study of IMC-11F8 in Participants With Colorectal Cancer

Eli Lilly and Company44 enrolled

Overview

The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

IMC-11F8 (necitumumab)BIOLOGICAL

IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1

OxaliplatinDRUG

Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1

Folinic acid (FA)DRUG

FA 400 mg/m² IV infusion bolus injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC * Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum * At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area * Age ≥18 years * Life expectancy of ≥6 months * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry * Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5 x 10\^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x 10\^9/L * Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) ≤2.5 x ULN (or 5.0 x ULN in the case of liver metastases) * Adequate renal function as defined by a serum creatinine ≤1.5 x ULN, creatinine clearance ≥ 60 milliliters per minute (mL/min), or serum albumin ≥lower limit of normal (LLN) * Participant's relevant toxicities/effects of prior therapy \[surgery/radiation therapy (RT)\] must have recovered to a stable or chronic level * Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant. * Participant has provided signed Informed Consent Exclusion Criteria: * Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC. * Has received prior radiotherapy to \>25% of bone marrow * Has documented and/or symptomatic brain metastases * Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry * Has received previous therapy with monoclonal antibodies * Has received previous therapy with any agent that targets the EGFR * Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study. * On chronic non-topical corticosteroid treatment for \>6 months at doses \>10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study * Has a known dihydropyrimidine dehydrogenase deficiency * Has a known allergy to any of the treatment components * Has an acute or subacute intestinal occlusion * Has peripheral neuropathy ≥Grade 2 * Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix * If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding * Has received a prior autologous or allogeneic organ or tissue transplantation * Has interstitial pneumonia or interstitial fibrosis of the lung * Has pleural effusion or ascites that causes ≥Grade 2 dyspnea * Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent

Locations (5)

ImClone Investigational Site

Brussels, Belgium

ImClone Investigational Site

Haine-Saint-Paul, Belgium

ImClone Investigational Site

Barcelona, Spain

ImClone Investigational Site

Madrid, Spain

Outcomes

Primary Outcomes

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )

CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) \* 100.

Time frame: Up to 30 Months

Secondary Outcomes

Overall Survival (OS)

OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.

Time frame: First dose to date of death from any cause up to 30 months

Progression-Free Survival (PFS)

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.

Time frame: First dose to measured PD or death up to 30 months

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death

The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Data from ClinicalTrials.gov

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