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CompletedNCT00835185Updated Jan 29, 2016Results posted

Study of IMC-11F8 in Participants With Colorectal Cancer

A Phase 2 interventional study of IMC-11F8 (necitumumab) and Oxaliplatin in Metastatic Colorectal Cancer, sponsored by Eli Lilly and Company. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Metastatic Colorectal Cancer

Keywords

  • Antibodies, Monoclonal
  • Colorectal Neoplasms
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 44 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

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

    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

  • BiologicalIMC-11F8 (necitumumab)

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

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

  • DrugOxaliplatin

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

  • DrugFolinic acid (FA)

    FA 400 mg/m² IV infusion bolus injection

  • Drug5-FU

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

06

What researchers measure

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.

    Time frame: Up to 30 Months

Secondary outcomes

  1. 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

  2. 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

  3. 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.

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

  4. Duration of Response

    The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥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. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.

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

  5. Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)

    A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.

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

  6. Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1

    Time frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

  7. Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1

    Time frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

  8. Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1

    The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.

    Time frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

  9. Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1

    CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.

    Time frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

  10. Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1

    Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.

    Time frame: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

  11. Cmax at Study Day 1 of Cycles 2 Through 6

    Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose

  12. Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6

    Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose

  13. t1/2 at Study Day 1 of Cycles 2 Through 6

    Time frame: Day 1 Cycles 2 through 6 predose and 1 hour post dose

  14. CL at Study Day 1 of Cycles 2 Through 6

    Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose

  15. Vss at Study Day 1 of Cycles 2 Through 6

    Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose

  16. Change From Baseline in Tumor Size

    Time frame: Baseline, 29 Months

  17. Kirsten Rat Sarcoma (KRAS) Mutation Status

    Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.

    Time frame: Baseline

07

Results

Posted Jan 29, 2016

Participant flow

Participant flow — Overall Study
MilestoneIMC-11F8 (Necitumumab) + mFOLFOX-6
Started44
Received at least 1 dose of study drug44
Completed44
Not completed0

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
percentage of participantsIMC-11F8 (Necitumumab) + mFOLFOX-6
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )63.6 (47.8 to 77.6)
SecondaryOverall 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
Reported as:
Median · months
Overall Survival (OS)
monthsIMC-11F8 (Necitumumab) + mFOLFOX-6
Overall Survival (OS)22.5 (11.0 to 30.0)
SecondaryProgression-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
Reported as:
Median · months
Progression-Free Survival (PFS)
monthsIMC-11F8 (Necitumumab) + mFOLFOX-6
Progression-Free Survival (PFS)10.0 (7.0 to 12.0)
SecondaryNumber 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.

Time frame:
First dose to end of treatment and 30-day post treatment follow-up up to 31 months
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death
participantsIMC-11F8 (Necitumumab) + mFOLFOX-6
AEs44
SAEs16
Deaths3
SecondaryDuration of Response

The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥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. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.

Time frame:
Time of response to time of measured PD or death up to 30 months
Reported as:
Median · months
Duration of Response
monthsIMC-11F8 (Necitumumab) + mFOLFOX-6
Duration of Response10.0 (7.0 to 16.0)
SecondarySerum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)

A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.

Time frame:
Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)
Reported as:
Number · participants
Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)
participantsIMC-11F8 (Necitumumab) + mFOLFOX-6
Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)4
SecondaryMaximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1
Time frame:
Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Reported as:
Geometric mean · micrograms/milliliter (µg/mL)
Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1
micrograms/milliliter (µg/mL)IMC-11F8 (Necitumumab) + mFOLFOX-6
Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1344 ± 46
SecondaryArea Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1
Time frame:
Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Reported as:
Geometric mean · micrograms*hour/milliliter (µg*h/mL)]
Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1
micrograms*hour/milliliter (µg*h/mL)]IMC-11F8 (Necitumumab) + mFOLFOX-6
Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 139400 ± 35
SecondaryHalf-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1

The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.

Time frame:
Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Reported as:
Geometric mean · hours (h)
Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1
hours (h)IMC-11F8 (Necitumumab) + mFOLFOX-6
Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1142 (99.8 to 299)
SecondaryClearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1

CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.

Time frame:
Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Reported as:
Geometric mean · milliliters/hour (mL/h)
Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1
milliliters/hour (mL/h)IMC-11F8 (Necitumumab) + mFOLFOX-6
Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 120.3 ± 35
SecondaryVolume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1

Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.

Time frame:
Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Reported as:
Geometric mean · milliliters (mL)
Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1
milliliters (mL)IMC-11F8 (Necitumumab) + mFOLFOX-6
Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 13660 ± 32
SecondaryCmax at Study Day 1 of Cycles 2 Through 6
Time frame:
Day 1 Cycles 2 through 6 predose and 1 hour postdose

No measurements were reported for this outcome.

SecondaryArea Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6
Time frame:
Day 1 Cycles 2 through 6 predose and 1 hour postdose

No measurements were reported for this outcome.

Secondaryt1/2 at Study Day 1 of Cycles 2 Through 6
Time frame:
Day 1 Cycles 2 through 6 predose and 1 hour post dose

No measurements were reported for this outcome.

SecondaryCL at Study Day 1 of Cycles 2 Through 6
Time frame:
Day 1 Cycles 2 through 6 predose and 1 hour postdose

No measurements were reported for this outcome.

SecondaryVss at Study Day 1 of Cycles 2 Through 6
Time frame:
Day 1 Cycles 2 through 6 predose and 1 hour postdose

No measurements were reported for this outcome.

SecondaryChange From Baseline in Tumor Size
Time frame:
Baseline, 29 Months

No measurements were reported for this outcome.

SecondaryKirsten Rat Sarcoma (KRAS) Mutation Status

Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.

Time frame:
Baseline
Reported as:
Number · participants
Kirsten Rat Sarcoma (KRAS) Mutation Status
participantsIMC-11F8 (Necitumumab) + mFOLFOX-6
KRAS Mutation Positive9
KRAS Mutation Negative16

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IMC-11F8 (Necitumumab) + mFOLFOX-6—16/44 (36.4%)44/44 (100%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventIMC-11F8 (Necitumumab) + mFOLFOX-6
Intestinal obstructionGastrointestinal disorders3/44
DiarrhoeaGastrointestinal disorders2/44
Febrile neutropeniaBlood and lymphatic system disorders1/44
Abdominal painGastrointestinal disorders1/44
Gastrointestinal obstructionGastrointestinal disorders1/44
Large intestine perforationGastrointestinal disorders1/44
Rectal haemorrhageGastrointestinal disorders1/44
VomitingGastrointestinal disorders1/44
General physical health deteriorationGeneral disorders1/44
Medical device complicationGeneral disorders1/44
Most frequent other events
Showing 10 of 48
Most frequent other events
EventIMC-11F8 (Necitumumab) + mFOLFOX-6
AstheniaGeneral disorders36/44
RashSkin and subcutaneous tissue disorders31/44
DiarrhoeaGastrointestinal disorders24/44
NeutropeniaBlood and lymphatic system disorders23/44
Mucosal inflammationGeneral disorders19/44
Decreased appetiteMetabolism and nutrition disorders18/44
NauseaGastrointestinal disorders17/44
VomitingGastrointestinal disorders16/44
ParonychiaInfections and infestations16/44
ParaesthesiaNervous system disorders16/44

Baseline characteristics

All enrolled participants who received any quantity of study drug.

Age, Continuous
Age, Continuous(years)IMC-11F8 (Necitumumab) + mFOLFOX-6
Mean63.3 ± 11.75
Sex: Female, Male
Sex: Female, Male(Participants)IMC-11F8 (Necitumumab) + mFOLFOX-6
Female19
Male25
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)IMC-11F8 (Necitumumab) + mFOLFOX-6
Hispanic or Latino31
Not Hispanic or Latino13
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)IMC-11F8 (Necitumumab) + mFOLFOX-6
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White42
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)IMC-11F8 (Necitumumab) + mFOLFOX-6
Belgium13
Spain31
08

Study locations

5 sites
  • ImClone Investigational Site
    Brussels, 1000, Belgium
  • ImClone Investigational Site
    Haine Saint-Paul, 7100, Belgium
  • ImClone Investigational Site
    Barcelona, 08035, Spain
  • ImClone Investigational Site
    Madrid, 28040, Spain
  • ImClone Investigational Site
    Valencia, 46010, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00835185
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Feb 3, 2009
Start date
Aug 2007
Primary completion
Jan 2010
Completion
Oct 2010
Results posted
Jan 29, 2016
Last update
Jan 29, 2016

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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