Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

IMC-A12 10 milligrams per kilogram (mg/kg) over one hour every two weeks. A cycle is defined as four weeks of therapy. Participants will continue on study until evidence of progressive disease, or unacceptable toxicity develops.

IMC-A12 (cixutumumab)

IMC-A12 10 mg/kg over one hour followed by cetuximab 500 milligrams per square meter (mg/m\^2) over two hours. This sequence will be repeated every two weeks. Participants will continue on study until evidence of progressive disease or unacceptable toxicity develops.

cetuximab (Erbitux ®)

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.

The routine cancer treatments for Squamous Cell Carcinoma Head and Neck Cancer have improved but still leave a percentage of participants with incurable disease. New alternatives for participants whose disease is refractory to existing therapies is needed.

IMC-A12 is a monoclonal antibody which binds to special receptors known as insulin-like growth factor-I receptor (IGF-IR). This binding action has been shown to inhibit the growth of a variety of human tumor cell lines.

The purpose of this study is to evaluate the effects of IMC-A12 by itself or with Cetuximab (Erbitux®) in participants with Squamous Cell Carcinoma Head and Neck Cancer that has spread to other parts of the body, and to determine how long the drug remains in the body. The study will also look at what side effects IMC-A12 may cause when a participant is receiving treatment.

Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck

A Randomized Phase 2 Open-Label Study of IMC-A12, as a Single Agent or in Combination With Cetuximab, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Disease Progression on Prior Platinum-Based Chemotherapy

PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.

ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants is calculated as a total number of participants with CR or PR divided by the total number of participants treated then multiplied by 100.

PFS at 6 months was defined as the percentage of participants who have neither experienced PD nor died at 6 months after the date of randomization. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 6 months divided by the total number of participants treated then multiplied by 100.

OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.

The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of PD or death. Response was defined using RECIST, version 1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of PD.

TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). Data presented are the number of participants who experienced TEAEs including serious TEAEs, and deaths during the study including the 30-day follow-up. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events section of this report.

No data for biomarkers and serum antibodies were collected due to lack of an appropriate validated assay.

Eli Lilly and Company

IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

IMC-A12 (Cixutumumab)

IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m\^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

IMC-A12 (Cixutumumab) + Cetuximab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Height

Weight

BSA is the measured or calculated surface area of a human body based on body weight and height.

The Mosteller¹ formula to calculate BSA (m\^2) = (\[Height (centimeter) x Weight (kilograms)\]/ 3600)½.

Body Surface Area (BSA)

Normal

Abnormal

Electrocardiogram (ECG)

0 = Fully Active

1 = Ambulatory, Restricted Work Activity

2 = Ambulatory, No Work Activity

ECOG performance status was used to classify participants according to their functional impairment. Score 0 = Fully active, able to carry on all pre-disease performance without restriction. Score 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work. Score 2 = Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.

Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score

Randomized participants who received at least 1 dose of study drug.

Chief Medical Officer

Randomized participants who received at least 1 dose of study drug. Seven (7) participants in IMC-A12 (Cixutumumab) and 4 participants in IMC-A12 (Cixutumumab) + Cetuximab were censored for analysis.

Progression-Free Survival (PFS)

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Percentage of Participants With PFS at 6 Months

Randomized participants who received at least 1 dose of study drug. Eleven (11) participants in IMC-A12 (Cixutumumab) group and 6 participants in IMC-A12 (Cixutumumab) + Cetuximab group were censored for analysis.

Overall Survival (OS)

Randomized participants who received at least 1 dose of study drug and had CR or PR. No participants were censored for duration of response.

Duration of Response

TEAEs

Serious TEAEs

Death due to AEs

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths

No participants were analyzed due to lack of an appropriate validated assay.

Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab

IMC-A12 (cixutumumab) 10 milligrams per kilogram (mg/kg) dose administered as an intravenous (IV) infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy. (4-week cycle). Treatment was continued until there was evidence of progressive disease (PD), unacceptable toxicity, or withdrawal of consent.

IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 milligrams per square meter (mg/m\^2) administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck	NCT00617734	Head and Neck C...	IMC-A12 (cixutu... cetuximab (Erbi...	18 Years -	Eli Lilly and Company
Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck	NCT00617734	Head and Neck C...	IMC-A12 (cixutu... cetuximab (Erbi...	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for cetuximab (erbitux ®)