Metastatic Colorectal CancerPhase 2NCT00835185
Study of IMC-11F8 in Participants With Colorectal Cancer
A Phase 2 study testing IMC-11F8 (necitumumab), Oxaliplatin and Folinic acid (FA) in people with Metastatic Colorectal Cancer, run by Eli Lilly and Company at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- IMC-11F8 (necitumumab), Oxaliplatin and Folinic acid (FA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2007to Oct 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Spain3 sites
ImClone Investigational Site
Barcelona, 08035
ImClone Investigational Site
Madrid, 28040
ImClone Investigational Site
Valencia, 46010
Belgium2 sites
ImClone Investigational Site
Brussels, 1000
ImClone Investigational Site
Haine-Saint-Paul, 7100
About this study
Official title: 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 (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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- IMC-11F8 (necitumumab), Oxaliplatin, Folinic acid (FA), 5-FU
- Keywords
- Antibodies, Monoclonal, Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-11F8 (necitumumab)Biological
Also called Necitumumab, IMC-11F8, LY3012211, Portrazza®
IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1
OxaliplatinDrug
Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1
Folinic acid (FA)Drug
FA 400 mg/m² IV infusion bolus injection
5-FUDrug
5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: IMC-11F8 (necitumumab); Drug: Oxaliplatin; Drug: Folinic acid (FA); Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 Months
Secondary outcomes (17)
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.
Measured: First dose to date of death from any cause up to 30 months
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.
Measured: First dose to measured PD or death up to 30 months
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.
Measured: First dose to end of treatment and 30-day post treatment follow-up up to 31 months
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.
Measured: Time of response to time of measured PD or death up to 30 months
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.
Measured: Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)
Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1
Measured: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1
Measured: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
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.
Measured: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
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.
Measured: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
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.
Measured: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Cmax at Study Day 1 of Cycles 2 Through 6
Measured: Day 1 Cycles 2 through 6 predose and 1 hour postdose
Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6
Measured: Day 1 Cycles 2 through 6 predose and 1 hour postdose
t1/2 at Study Day 1 of Cycles 2 Through 6
Measured: Day 1 Cycles 2 through 6 predose and 1 hour post dose
CL at Study Day 1 of Cycles 2 Through 6
Measured: Day 1 Cycles 2 through 6 predose and 1 hour postdose
Vss at Study Day 1 of Cycles 2 Through 6
Measured: Day 1 Cycles 2 through 6 predose and 1 hour postdose
Change From Baseline in Tumor Size
Measured: Baseline, 29 Months
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startAug 2007
- Primary completionJan 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835185
- Sponsor's protocol ID
- 13926
- Other IDs
- 2006-003147-23, CP11-0602, I4X-IE-JFCD
- Status last verified
- Dec 2015
- First submitted
- 2 Feb 2009
- Last updated
- 29 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00835185
- Acronym / sponsor ID
- 13926
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Antibodies, Monoclonal, Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 29 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMC-11F8 (necitumumab) /mFOLFOX-6 regimen | Experimental | Biological: IMC-11F8 (necitumumab), Drug: Oxaliplatin, Drug: Folinic acid (FA), Drug: 5-FUParticipants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-11F8 (necitumumab)Also: Necitumumab, IMC-11F8, LY3012211, Portrazza®IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 | Biological | IMC-11F8 (necitumumab) /mFOLFOX-6 regimen |
| OxaliplatinOxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 | Drug | IMC-11F8 (necitumumab) /mFOLFOX-6 regimen |
| Folinic acid (FA)FA 400 mg/m² IV infusion bolus injection | Drug | IMC-11F8 (necitumumab) /mFOLFOX-6 regimen |
| 5-FU5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours | Drug | IMC-11F8 (necitumumab) /mFOLFOX-6 regimen |
Primary outcome
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
Time frame: Up to 30 Months
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.
17 secondary outcomes
Overall Survival (OS)
Time frame: First dose to date of death from any cause up to 30 months
Progression-Free Survival (PFS)
Time frame: First dose to measured PD or death up to 30 months
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death
Time frame: First dose to end of treatment and 30-day post treatment follow-up up to 31 months
Duration of Response
Time frame: Time of response to time of measured PD or death up to 30 months
Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)
Time frame: Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)
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
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
Half-Life (t1/2) 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
Clearance (CL) 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
Volume of Distribution (Vss) 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
Cmax at Study Day 1 of Cycles 2 Through 6
Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose
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
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
CL at Study Day 1 of Cycles 2 Through 6
Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose
Vss at Study Day 1 of Cycles 2 Through 6
Time frame: Day 1 Cycles 2 through 6 predose and 1 hour postdose
Change From Baseline in Tumor Size
Time frame: Baseline, 29 Months
Kirsten Rat Sarcoma (KRAS) Mutation Status
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMC-11F8 (necitumumab), Oxaliplatin and Folinic acid (FA) in people with Metastatic Colorectal Cancer, run by Eli Lilly and Company at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response ) (time frame: Up to 30 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.