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 | Completed Phase 2 Results

• 4 other identifiers: 13913CP13-0706CP02-0758I5A-IE-JAEB
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Squamous Cell Carcinoma in Head and Neck; Prior Platinum-based chemotherapy; Cetuximab; Erbitux; IMC-A12

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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.

  Baseline to measured PD (up to 27.66 months)

Secondary Outcomes (6)

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

  Baseline to measured PD (up to 27.66 months)

• Percentage of Participants With PFS at 6 Months

  6 months

• Overall Survival (OS)

  Baseline to date of death from any cause (up to 29.63 months)

• Duration of Response

  Date of first response to the date of PD or death due to any cause (up to 23.98 months)

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

  Baseline through study completion (up to 29.63 months)

Study Arms (2)

IMC-A12 (cixutumumab)

EXPERIMENTAL

Biological: IMC-A12 (cixutumumab)

IMC-A12 (cixutumumab) + cetuximab

EXPERIMENTAL

Biological: IMC-A12 (cixutumumab); Biological: cetuximab (Erbitux ®)

Interventions

IMC-A12 (cixutumumab) BIOLOGICAL

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.

Also known as: Cixutumumab, LY3012217

IMC-A12 (cixutumumab); IMC-A12 (cixutumumab) + cetuximab

cetuximab (Erbitux ®) BIOLOGICAL

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.

Also known as: Erbitux®

IMC-A12 (cixutumumab) + cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical imaging studies
• Measurable disease, lesion size ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
• Clinical documentation of disease progression during treatment with or within 90 days after receiving the last cycle of platinum-based chemotherapy (with or without radiation therapy)
• If prior treatment with anti-epidermal growth factor receptor (EGFR) therapy, the time to recurrence from last exposure to anti-EGFR therapy is \> 90 days
• Adequate hematologic function
• Adequate hepatic function
• Adequate coagulation function or is on a stable dose of an anticoagulant.
• Adequate renal function
• Fasting serum glucose \<120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

You may not qualify if:

• Not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, must have recovered to grade ≤ 2
• Is receiving any other investigational agent(s)
• History of treatment with other agents targeting the insulin-like growth factor receptor (IGFR)
• Is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
• History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or IMC-A12
• Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting \< 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
• Pregnant or breastfeeding
• Is receiving therapy with immunosuppressive agents

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

ImClone Investigational Site

Orange, California, 92868, United States

Location

ImClone Investigational Site

Miami, Florida, 33136, United States

Location

ImClone Investigational Site

Orlando, Florida, 32806, United States

Location

ImClone Investigational Site

Atlanta, Georgia, 30322, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60637, United States

Location

ImClone Investigational Site

Baltimore, Maryland, 21231, United States

Location

ImClone Investigational Site

Boston, Massachusetts, 02115, United States

Location

ImClone Investigational Site

Rochester, Minnesota, 55905, United States

Location

ImClone Investigational Site

New York, New York, 10003, United States

Location

ImClone Investigational Site

The Bronx, New York, 10467, United States

Location

ImClone Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

Location

ImClone Investigational Site

Nashville, Tennessee, 37232, United States

Location

ImClone Investigational Site

Houston, Texas, 77030, United States

Location

ImClone Investigational Site

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

cixutumumab; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 18, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Locations

US (14)