Study of IMC-11F8 in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00835185
First received: February 2, 2009
Last updated: January 22, 2014
Last verified: July 2011

February 2, 2009
January 22, 2014
August 2007
January 2010   (final data collection date for primary outcome measure)
Overall response (OOR) [ Time Frame: Approximately 30 Months ] [ Designated as safety issue: No ]
Anti-Tumor Activity of IMC-11F8 [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00835185 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Clearance (Cl) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Volume of Distribution (Vss) at study day 1 (cycle 1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Half-life (t 1/2) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Clearance (Cl) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Volume of Distribution (Vss) at study day 1 (cycles 2-6, etc) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Change from baseline in tumor size [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
  • KRAS mutation status [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]
    Tumor tissue samples will be screened for the presence or absence of KRAS mutations
  • Overall Survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: Every 4 cycle ] [ Designated as safety issue: No ]
  • Safety Profile [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]
  • Pharmacokinetic Profile & Immunogenicity [ Time Frame: Cycles 1-6 and end of treatment ] [ Designated as safety issue: Yes ]
  • Association between response to treatment and the presence or absence of KRAS mutations in tumor tissue [ Time Frame: Every 4 cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of IMC-11F8 in Patients With Colorectal Cancer
Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer

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

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Biological: IMC-11F8 (Necitumumab)
    IMC-11F8 800 mg intravenous infusion over 50 minutes on Day 1
    Other Names:
    • Necitumumab
    • IMC-11F8
  • Other: mFOLFOX-6 regimen
    Oxaliplatin 85 mg/m2 intravenous infusion over 2 hours Day 1
  • Drug: Folinic acid
    5-FU 400 mg/m2 intravenous infusion bolus injection
  • Drug: 5-FU
    2400 mg/m2 IV continuous infusion over 46 hours
Experimental: IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
Participants will receive IMC-11F8 (necitumumab) once every two weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
Interventions:
  • Biological: IMC-11F8 (Necitumumab)
  • Other: mFOLFOX-6 regimen
  • Drug: Folinic acid
  • Drug: 5-FU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
October 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically-confirmed, EGFR-detectable or EGFR-undetectable colorectal cancer
  • Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
  • At least one unidimensional-measurable target lesion by CT scan or 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 ANC ≥ 1.5 x 10^9 L, hemoglobin ≥ 10 g/dL, and platelets ≥ 100 x 10^9/L
  • Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, AST and ALT ≤ 2.5 x Upper Limit of Normal (ULN), and alkaline phosphatase ≤ 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 mL/min, or serum albumin ≥ LLN
  • Patient's relevant toxicities/effects of prior therapy (surgery/RT) must have recovered to a stable or chronic level
  • Patient agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Patients must notify the principal investigator if they themselves or their partner becomes pregnant.
  • Patient 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 epidermal growth factor receptor
  • Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the patient or study.
  • On chronic non-topical corticosteroid treatment for > 6 months at doses > 10 mg/day of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the patient 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Spain
 
NCT00835185
13926, 2006-003147-23, CP11-0602, I4X-IE-JFCD
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP