Study of IMC-11F8 in Participants With Colorectal Cancer

NCT00835185 | Completed Phase 2 Results

• 4 other identifiers: 139262006-003147-23CP11-0602I4X-IE-JFCD
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Keywords

Antibodies, Monoclonal; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 Months

Secondary Outcomes (17)

• Overall Survival (OS)

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

• Progression-Free Survival (PFS)

  First dose to measured PD or death up to 30 months

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

  First dose to end of treatment and 30-day post treatment follow-up up to 31 months

• Duration of Response

  Time of response to time of measured PD or death up to 30 months

• Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)

  Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)

Study Arms (1)

IMC-11F8 (necitumumab) /mFOLFOX-6 regimen

EXPERIMENTAL

Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)

Biological: IMC-11F8 (necitumumab); Drug: Oxaliplatin; Drug: Folinic acid (FA); Drug: 5-FU

Interventions

IMC-11F8 (necitumumab) BIOLOGICAL

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

Also known as: Necitumumab, IMC-11F8, LY3012211, Portrazza®

IMC-11F8 (necitumumab) /mFOLFOX-6 regimen

Oxaliplatin DRUG

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

IMC-11F8 (necitumumab) /mFOLFOX-6 regimen

Folinic acid (FA) DRUG

FA 400 mg/m² IV infusion bolus injection

IMC-11F8 (necitumumab) /mFOLFOX-6 regimen

5-FU DRUG

5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

IMC-11F8 (necitumumab) /mFOLFOX-6 regimen

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

ImClone Investigational Site

Brussels, 1000, Belgium

Location

ImClone Investigational Site

Haine-Saint-Paul, 7100, Belgium

Location

ImClone Investigational Site

Barcelona, 08035, Spain

Location

ImClone Investigational Site

Madrid, 28040, Spain

Location

ImClone Investigational Site

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

necitumumab; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: August 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 29, 2016
• Results First Posted: January 29, 2016

Record last verified: 2015-12

Locations

BE (2); ES (3)