CancerPhase 1NCT00786383
Study of IMC-1121B in Patients With Advanced Solid Tumors Not Responding To Standard Therapy
A Phase 1 study testing IMC-1121B and 1121B in people with Cancer, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- IMC-1121B and 1121B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2006to Jan 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with histopathologically-documented, measurable or evaluable (non-measurable), advanced primary or recurrent solid tumors who have not responded to standard therapy or for whom no standard therapy is available
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 at study entry.
- Able to provide written informed consent.
- A life expectancy of >3 months.
- Adequate hematologic function, as defined by:
- an absolute neutrophil count ≥1500/mm3
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- a hemoglobin level ≥10 gm/dL
- a platelet count ≥100,000/mm3
- Adequate hepatic function, as defined by:
- a total bilirubin level ≤1.5 x the upper limit of normal (ULN)
- aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤2.5 x the ULN or ≤5 x the ULN if known liver metastases
- Adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN.
- Use of effective contraception , if procreative potential exists.
- Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy
- Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.
Who cannot join
- Patients with large centrally-located pulmonary lesions adjacent to or invading large blood vessels.
- Patients who have had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients with ongoing side effects ≥ grade 2 due to agents administered more than 28 days earlier.
- Prior left chest wall radiotherapy or a cumulative anthracycline dose ≥300 mg/m2 (if the ejection fraction is within normal institutional limits, the patient can be enrolled).
- Any concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥3 years will be allowed to enter the trial.
- Uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection requiring parenteral antibiotics
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- symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)
- unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- uncontrolled hypertension (systolic blood pressure ≥160 mm Hg, diastolic blood pressure >100 mm Hg, found on two consecutive measurements separated by a 1-week period despite adequate medical support)
- clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia)
- uncontrolled diabetes
- psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
- patients with symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids; anticonvulsants are allowed)
- A serious or nonhealing active wound, ulcer, or bone fracture.
- Known human immunodeficiency-positivity.
- A major surgical procedure, an open biopsy, or a significant traumatic injury within 28 days prior to treatment.
- Current or recent use (within 28 days) of a thrombolytic agent.
- Current or recent use (within 28 days) of full-dose warfarin (an exception is low-dose warfarin to maintain patency of preexisting, permanent, indwelling intravenous (i.v.) catheters; for patients receiving warfarin, the international normalized ratio [INR] should be <1.5). Patients requiring heparin are excluded.
- Chronic daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function (cyclooxygenase-2 [COX-2] inhibitors are permitted).
- A history or clinical evidence of a deep venous or arterial thrombosis (including pulmonary embolism) within the last 6 months prior to study entry.
- Proteinuria ≥1+ by routine urinalysis (patients with a protein value of ≤500 mg confirmed by a 24-hour urine collection are eligible).
- Pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG]) or breast feeding.
- Prior treatment with bevacizumab or other agents specifically targeting VEGF ligand or receptor within 6 weeks of study entry.
- Monoclonal antibodies within 6 weeks of study entry.
- Positive anti-IMC-1121B antibody response.
- A history of allergic reactions to monoclonal antibodies or other therapeutic proteins.
- The subject is the investigator, sub-investigator, or anyone directly involved in the conduct of the protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ImClone Investigational Site
Durham, North Carolina, 27710
ImClone Investigational Site
Indianapolis, Indiana, 46202-5112
ImClone Investigational Site
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase 1 Study of Every Other Week Anti-Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Monoclonal Antibody IMC-1121B in Patients With Advanced Solid Tumors Who Have Not Responded To Standard Therapy
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study.
We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Read the detailed description
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study.
In order for a cancer to grow, it needs blood vessels to bring to it oxygen and food. Cancer cells can make growth factors that cause the abnormal growth of new blood vessels. This is called angiogenesis. Normally, new blood vessels do not grow in adults. Angiogenesis inhibitors are drugs that may prevent abnormal growth of blood vessels to tumors. IMC-1121B is an angiogenesis inhibitor. We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
- Conditions
- Cancer
- Being tested
- IMC-1121B, 1121B
- Keywords
- Phase I, cancer, solid tumors, 1121B, VEGFR-2, Anti-Vascular Endothelial Growth Factor Receptor 2
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-1121BBiological
Cohort 1
6 mg/kg I.V., once every other week for 4 weeks
1121BBiological
Cohort 2
8mg/kg I.V., once every other week for 4 weeks
1121BBiological
Cohort 3
10 mg/kg I.V., once every other week for 4 weeks
1121BBiological
Cohort 4
15 mg/kg I.V., once every 3 weeks for 6 weeks
1121BBiological
Cohort 5
20 mg/kg I.V., once every 3 weeks for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| IMC-1121B | Experimental | IMC-1121B injectable solution at a concentration of 5 mg/mL in single-use vials containing 100 mg/20 mL or 250 mg/50 mL of product, administered intravenously at an initial dose of 6 mg/kg.A minimum of three patients will be enrolled into each cohort. When all patients complete a cohort, dose escalation to the next cohort will occur. Receives: Biological: IMC-1121B; Biological: 1121B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Measured: 8 Weeks
Maximum Tolerated Dose
Measured: 8 Weeks
Secondary outcomes (8)
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5
Measured: 8 Weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5
Measured: 8 Weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5
Measured: 8 Weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5
Measured: 8 Weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5
Measured: 8 Weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5
Measured: 8 Weeks
Serum Anti-IMC-1121B Antibody Assessment (immunogenicity)
Measured: 8 Weeks
Change in tumor size from Baseline Measurement
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startFeb 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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 chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786383
- Sponsor's protocol ID
- 13919
- Other IDs
- CP12-0402, I4T-IE-JVBN
- Status last verified
- Aug 2013
- First submitted
- 4 Nov 2008
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiorean EG, Hurwitz HI, Cohen RB, Schwartz JD, Dalal RP, Fox FE, Gao L, Sweeney CJ. Phase I study of every 2- or 3-week dosing of ramucirumab, a human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2 in patients with advanced solid tumors. Ann Oncol. 2015 Jun;26(6):1230-1237. doi: 10.1093/annonc/mdv144. Epub 2015 Mar 18.
PubMed 25787923
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Every Other Week Anti-Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Monoclonal Antibody IMC-1121B in Patients With Advanced Solid Tumors Who Have Not Responded To Standard Therapy
- ClinicalTrials.gov ID
- NCT00786383
- Acronym / sponsor ID
- 13919
- Conditions
- Cancer
- Keywords
- Phase I, cancer, solid tumors, 1121B, VEGFR-2, Anti-Vascular Endothelial Growth Factor Receptor 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study.
We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Detailed description
We are conducting a research study for tumors that have not responded to prior treatment. The subject will receive an investigational drug called IMC-1121B. ImClone LLC, the maker of IMC-1121B, is running this research study.
In order for a cancer to grow, it needs blood vessels to bring to it oxygen and food. Cancer cells can make growth factors that cause the abnormal growth of new blood vessels. This is called angiogenesis. Normally, new blood vessels do not grow in adults. Angiogenesis inhibitors are drugs that may prevent abnormal growth of blood vessels to tumors. IMC-1121B is an angiogenesis inhibitor. We believe that IMC-1121B blocks the growth factors made by the cancer cells, so new blood vessels do not grow. It is believed that without the new blood vessels, the cancer or tumor will not get the oxygen and food that it needs to grow. This may stop the cancer from growing or spreading and the tumor cells may die. Since normal blood vessels have already formed in adults, it might be possible to stop tumor growth without harming normal cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMC-1121B | Experimental | Biological: IMC-1121B, Biological: 1121BIMC-1121B injectable solution at a concentration of 5 mg/mL in single-use vials containing 100 mg/20 mL or 250 mg/50 mL of product, administered intravenously at an initial dose of 6 mg/kg.A minimum of three patients will be enrolled into each cohort. When all patients complete a cohort, dose escalation to the next cohort will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histopathologically-documented, measurable or evaluable (non-measurable), advanced primary or recurrent solid tumors who have not responded to standard therapy or for whom no standard therapy is available
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 at study entry.
- Able to provide written informed consent.
- A life expectancy of >3 months.
- Adequate hematologic function, as defined by:
Key exclusion criteria (27 listed)
- Patients with large centrally-located pulmonary lesions adjacent to or invading large blood vessels.
- Patients who have had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients with ongoing side effects ≥ grade 2 due to agents administered more than 28 days earlier.
- Prior left chest wall radiotherapy or a cumulative anthracycline dose ≥300 mg/m2 (if the ejection fraction is within normal institutional limits, the patient can be enrolled).
- Any concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥3 years will be allowed to enter the trial.
- Uncontrolled intercurrent illness including, but not limited to:
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-1121BCohort 1 6 mg/kg I.V., once every other week for 4 weeks | Biological | IMC-1121B |
| 1121BCohort 2 8mg/kg I.V., once every other week for 4 weeks | Biological | IMC-1121B |
| 1121BCohort 3 10 mg/kg I.V., once every other week for 4 weeks | Biological | IMC-1121B |
| 1121BCohort 4 15 mg/kg I.V., once every 3 weeks for 6 weeks | Biological | IMC-1121B |
| 1121BCohort 5 20 mg/kg I.V., once every 3 weeks for 6 weeks | Biological | IMC-1121B |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: 8 Weeks
Maximum Tolerated Dose
Time frame: 8 Weeks
8 secondary outcomes
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5
Time frame: 8 Weeks
Serum Anti-IMC-1121B Antibody Assessment (immunogenicity)
Time frame: 8 Weeks
Change in tumor size from Baseline Measurement
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
- Derived from this study: PubMed 25787923Chiorean EG, Hurwitz HI, Cohen RB, Schwartz JD, Dalal RP, Fox FE, Gao L, Sweeney CJ. Phase I study of every 2- or 3-week dosing of ramucirumab, a human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2 in patients with advanced solid tumors. Ann Oncol. 2015 Jun;26(6):1230-1237. doi: 10.1093/annonc/mdv144. Epub 2015 Mar 18.
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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 chair
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMC-1121B and 1121B in people with Cancer, run by Eli Lilly and Company at 3 sites in United States.
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 15 inclusion and 27 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 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Adverse Events (AEs) (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786383, which also lists 1 linked publication.
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 19 Aug 2013.