Colorectal CarcinomaPhase 2NCT00862784
A Study of IMC-1121B (Ramucirumab) in Colorectal Cancer
A Phase 2 study testing IMC-1121B (ramucirumab), Oxaliplatin and Folinic acid in people with Colorectal Carcinoma, run by Eli Lilly and Company at 7 sites in 2 countries.
Trial summary
The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- IMC-1121B (ramucirumab), Oxaliplatin and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2009to Aug 2011
- 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
- The participant must have histologically confirmed adenocarcinoma of the colon or rectum that is locally-advanced or metastatic and unresectable
- The participant has at least one unidimensionally-measurable target lesion [≥ 2 centimeters (cm) with conventional techniques or ≥ 1 cm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by Response Evaluation Criteria in Solid Tumors (RECIST)]; target lesion(s) must not lie within an irradiated area. Participants with locally advanced rectal carcinoma who have undergone previous radiation must have documented evidence of disease progression in the pelvis in order to participate
- The participant is age ≥ 18 years
- The participant has a life expectancy of ≥ 6 months
- The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
- The participant has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1500/microliter (μL), hemoglobin ≥ 10 grams/deciliter (g/dL), and platelets ≥ 100,000/μL
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- The participant has adequate hepatic function as defined by: total bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (or 5.0 x ULN in the case of liver metastases), and serum albumin ≥ lower limit of normal (LLN) institutional range or (if < LLN) within 10% of the LLN
- The participant has adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 60 milliliters/minute (mL/min)
- The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis [(UA); if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study]
- The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight (LMW) heparin and if on warfarin, must have an INR between 2 and 3 and no active bleeding or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
- The participant has resolution to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to Grade 0
- The participant agrees to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment
- The participant has provided signed informed consent
Who cannot join
- The participant has received prior systemic chemotherapy for locally-advanced unresectable or metastatic colorectal cancer (CRC). Prior adjuvant chemotherapy is allowed if disease progression has been documented > 6 months after the end of the last cycle of adjuvant chemotherapy or > 12 months after the end of the last cycle of adjuvant oxaliplatin-containing regimens
- The participant has documented and/or symptomatic brain or leptomeningeal metastases
- The participant has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
- The participant has received previous therapy with monoclonal antibodies
- The participant has received previous therapy with any agent that targets vascular endothelial growth factor (VEGF) or VEGF receptor-2 (VEGFR-2) (including multi-targeted tyrosine kinase inhibitors)
- The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator
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- The participant is 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 participant or the study
- The participant has a known dihydropyrimidine dehydrogenase (DPD) deficiency
- The participant has a known allergy to any of the treatment components
- The participant has an acute or subacute intestinal obstruction
- The participant has uncontrolled or poorly controlled hypertension on a standard regimen of anti-hypertensive therapy
- The participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years
- The participant, if female, is pregnant
- Has had prior autologous or allogeneic organ or tissue transplantation
- Has interstitial pneumonia or interstitial fibrosis of the lung, which in the opinion of the investigator could compromise the participant or the study
- Has pleural effusion or ascites that causes > Grade 1 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
- Has undergone major surgery within 28 days prior to the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to the first dose of study medication
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Spain4 sites
ImClone Investigational Site
Barcelona
ImClone Investigational Site
Santander
ImClone Investigational Site
Seville
ImClone Investigational Site
Valencia
Canada3 sites
ImClone Investigational Site
Montreal, Quebec, H2L 4M1
ImClone Investigational Site
Ottawa, Ontario, K1H 8L6
ImClone Investigational Site
Toronto, Ontario, M5G-2M9
About this study
Official title: An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination With 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients With Metastatic Colorectal Cancer
The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.
Read the detailed description
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B (ramucirumab) in combination with the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] chemotherapy regimen as first-line therapy.
- Conditions
- Colorectal Carcinoma
- Being tested
- IMC-1121B (ramucirumab), Oxaliplatin, Folinic acid, 5-FU
- Keywords
- Colorectal carcinoma, CRC, Colon Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-1121B (ramucirumab)Biological
Also called ramucirumab, LY3009806
8 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks
OxaliplatinDrug
85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1
Folinic acidDrug
400 mg/m² intravenous infusion over 2 hours on Day 1
5-FUDrug
400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion
5-FUDrug
2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| IMC-1121B (ramucirumab) + mFOLFOX-6 | Experimental | This regimen will be repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. Receives: Biological: IMC-1121B (ramucirumab); Drug: Oxaliplatin; Drug: Folinic acid; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
Measured: First dose to measured progressive disease or death due to any cause up to 28.1 months
Secondary outcomes (16)
Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]
ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
Measured: First dose to date of objective progressive disease up to 23.8 months
Overall Survival (OS)
OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
Measured: First dose to death due to any cause up to 28.1 months
Duration of Response
The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.
Measured: Time of response to time of measured progressive disease up to 22.2 months
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Measured: First dose to 25.2 months
Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)
Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: First dose to 25.2 months
Maximum Concentration (Cmax) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, Cmax was not calculated.
Measured: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Area Under the Concentration (AUC) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, AUC was not calculated.
Measured: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Half-Life (t1/2) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, t1/2 was not calculated.
Measured: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Clearance (CL) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, CL was not calculated.
Measured: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, Vss was not calculated.
Measured: Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)
Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, Cmax was not calculated.
Measured: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, AUC was not calculated.
Measured: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, t1/2 was not calculated.
Measured: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, CL was not calculated.
Measured: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, Vss was not calculated.
Measured: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.
Measured: Day 1 (Cycles 1, 5, 9, and 30-day follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionAug 2011
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 Colorectal CarcinomaStudies 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
- 48 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
- NCT00862784
- Sponsor's protocol ID
- 13897
- Other IDs
- 2008-004936-19, CP12-0709, I4T-IE-JVBH, 2008
- Status last verified
- May 2014
- First submitted
- 16 Mar 2009
- Last updated
- 17 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination With 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00862784
- Acronym / sponsor ID
- 13897
- Conditions
- Colorectal Carcinoma
- Keywords
- Colorectal carcinoma, CRC, Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Posted 17 Jun 2014
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 test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.
Detailed description
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B (ramucirumab) in combination with the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] chemotherapy regimen as first-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMC-1121B (ramucirumab) + mFOLFOX-6 | Experimental | Biological: IMC-1121B (ramucirumab), Drug: Oxaliplatin, Drug: Folinic acid, Drug: 5-FUThis regimen will be repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The participant must have histologically confirmed adenocarcinoma of the colon or rectum that is locally-advanced or metastatic and unresectable
- The participant has at least one unidimensionally-measurable target lesion [≥ 2 centimeters (cm) with conventional techniques or ≥ 1 cm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by Response Evaluation Criteria in Solid Tumors (RECIST)]; target lesion(s) must not lie within an irradiated area. Participants with locally advanced rectal carcinoma who have undergone previous radiation must have documented evidence of disease progression in the pelvis in order to participate
- The participant is age ≥ 18 years
- The participant has a life expectancy of ≥ 6 months
- The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
Key exclusion criteria (18 listed)
- The participant has received prior systemic chemotherapy for locally-advanced unresectable or metastatic colorectal cancer (CRC). Prior adjuvant chemotherapy is allowed if disease progression has been documented > 6 months after the end of the last cycle of adjuvant chemotherapy or > 12 months after the end of the last cycle of adjuvant oxaliplatin-containing regimens
- The participant has documented and/or symptomatic brain or leptomeningeal metastases
- The participant has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
- The participant has received previous therapy with monoclonal antibodies
- The participant has received previous therapy with any agent that targets vascular endothelial growth factor (VEGF) or VEGF receptor-2 (VEGFR-2) (including multi-targeted tyrosine kinase inhibitors)
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-1121B (ramucirumab)Also: ramucirumab, LY30098068 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks | Biological | IMC-1121B (ramucirumab) + mFOLFOX-6 |
| Oxaliplatin85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1 | Drug | IMC-1121B (ramucirumab) + mFOLFOX-6 |
| Folinic acid400 mg/m² intravenous infusion over 2 hours on Day 1 | Drug | IMC-1121B (ramucirumab) + mFOLFOX-6 |
| 5-FU400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion | Drug | IMC-1121B (ramucirumab) + mFOLFOX-6 |
| 5-FU2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2 | Drug | IMC-1121B (ramucirumab) + mFOLFOX-6 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: First dose to measured progressive disease or death due to any cause up to 28.1 months
PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
16 secondary outcomes
Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]
Time frame: First dose to date of objective progressive disease up to 23.8 months
Overall Survival (OS)
Time frame: First dose to death due to any cause up to 28.1 months
Duration of Response
Time frame: Time of response to time of measured progressive disease up to 22.2 months
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Time frame: First dose to 25.2 months
Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)
Time frame: First dose to 25.2 months
Maximum Concentration (Cmax) at Day 1 of Cycle 1
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Area Under the Concentration (AUC) at Day 1 of Cycle 1
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Half-Life (t1/2) at Day 1 of Cycle 1
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Clearance (CL) at Day 1 of Cycle 1
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1
Time frame: Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)
Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
Time frame: Day 1 (Cycles 1, 5, 9, and 30-day follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
7 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-1121B (ramucirumab), Oxaliplatin and Folinic acid in people with Colorectal Carcinoma, run by Eli Lilly and Company at 7 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 13 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Canada. 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 17 Jun 2014). 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?
Progression-Free Survival (PFS) (time frame: First dose to measured progressive disease or death due to any cause up to 28.1 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 17 Jun 2014.