Advanced Solid TumorsPhase 1NCT00793975
Study of IMC-1121B in Patients With Tumors That Have Not Responded to Therapy
A Phase 1 study testing IMC-1121B and 1121B in people with Advanced Solid Tumors, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The purpose of this study is to determine if IMC-1121B is safe for patients, and to determine the best dose of IMC-1121B to give to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- 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
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Jun 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
- 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.
- 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: ANC ≥ 1500/mm^3, hemoglobin level ≥ 10 gm/dL, platelet count ≥ 100,000/mm^3
- Adequate hepatic function, as defined by: total bilirubin level ≤ 1.5 x the ULN, AST and ALT levels ≤ 2.5 x the ULN or ≤ 5 x the ULN if known liver metastases
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- Adequate renal function, as defined by a serum creatinine level ≤ 1.5 x the ULN
- Use of effective contraception (per the institutional standard), 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 (palliative radiation therapy is allowed).
- 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 ≥ 300mg/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 ≥ 3 years will be allowed to enter the trial.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months, uncontrolled hypertension, clinically significant cardiac arrhythmia, uncontrolled diabetes, psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements, patients with symptomatic brain metastases
- A serious or nonhealing active wound, ulcer, or bone fracture
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- Known HIV positivity
- A major surgical procedure, an open biopsy, or a significant 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
- Chronic daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
- History or clinical evidence of a deep venous or arterial thrombosis (including pulmonary embolism) within 6 months prior to study entry
- Proteinuria ≥1+ by routine urinalysis (patients with a protein value of ≤ 500mg 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
- History of allergic reactions to monoclonal antibodies or other therapeutic proteins
- Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members the employees.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ImClone Investigational Site
Aurora, Colorado, 80045
ImClone Investigational Site
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase I Study of Weekly 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
The purpose of this study is to determine if IMC-1121B is safe for patients, and to determine the best dose of IMC-1121B to give to patients.
Read the detailed description
The purpose of this study is to establish the safety profile and the maximum tolerated dose (MTD) of the anti-VEGFR-2 monoclonal antibody IMC-1121B administered weekly in patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.
- Conditions
- Advanced Solid Tumors
- Being tested
- IMC-1121B, 1121B
- Keywords
- Tumors, Antibodies, Monoclonal
- 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
2 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
1121BBiological
Cohort 2
4 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
1121BBiological
Cohort 3
6 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
1121BBiological
Cohort 4
8 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
1121BBiological
Cohort 5
10 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period.
1121BBiological
Cohort 6
13 mg/kg once a week for 4 weeks, followed by a 2-week observation period.
1121BBiological
Cohort 7
16 mg/kg once a week for 4 weeks, followed by a 2-week observation period.
| Study group | Role | What they receive |
|---|---|---|
| IMC-1121B | Experimental | All patients will receive intravenous infusions of IMC-1121B with the dose depending on which cohort they are enrolled into. A minimum of three patients will be enrolled in each cohort.
A completed patient will be either a patient who completes the 4-week treatment cycle and 2-week observation period (for a total of 6 weeks), or a patient who discontinues therapy for an IMC-1121B-related toxicity. Toxicity data for each cohort will be reviewed prior to dose escalation.
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: 6 weeks
Maximum Tolerated Dose
Measured: 6 weeks
Secondary outcomes (8)
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, 5, 6. and 7
Measured: 6 weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, 5, 6. and 7
Measured: 6 weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, 5, 6. and 7
Measured: 6 weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, 5, 6. and 7
Measured: 6 weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, 5, 6. and 7
Measured: 6 weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, 5, 6. and 7
Measured: 6 weeks
Serum Anti-IMC-1121B Antibody Assessment (immunogenicity)
Measured: 6 weeks
Change in tumor size from Baseline Measurement
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT00793975
- Sponsor's protocol ID
- 13918
- Other IDs
- CP12-0401, I4T-IE-JVBM
- Status last verified
- Aug 2013
- First submitted
- 14 Nov 2008
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
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 I Study of Weekly 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
- NCT00793975
- Acronym / sponsor ID
- 13918
- Conditions
- Advanced Solid Tumors
- Keywords
- Tumors, Antibodies, Monoclonal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 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.
The purpose of this study is to determine if IMC-1121B is safe for patients, and to determine the best dose of IMC-1121B to give to patients.
Detailed description
The purpose of this study is to establish the safety profile and the maximum tolerated dose (MTD) of the anti-VEGFR-2 monoclonal antibody IMC-1121B administered weekly in patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.
Study design
- 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: 1121BAll patients will receive intravenous infusions of IMC-1121B with the dose depending on which cohort they are enrolled into. A minimum of three patients will be enrolled in each cohort. A completed patient will be either a patient who completes the 4-week treatment cycle and 2-week observation period (for a total of 6 weeks), or a patient who discontinues therapy for an IMC-1121B-related toxicity. Toxicity data for each cohort will be reviewed prior to dose escalation. 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 (10 listed)
- 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.
- 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: ANC ≥ 1500/mm^3, hemoglobin level ≥ 10 gm/dL, platelet count ≥ 100,000/mm^3
Key exclusion criteria (19 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 ≥ 300mg/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 ≥ 3 years will be allowed to enter the trial.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months, uncontrolled hypertension, clinically significant cardiac arrhythmia, uncontrolled diabetes, psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements, patients with symptomatic brain metastases
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 2 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
| 1121BCohort 2 4 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
| 1121BCohort 3 6 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
| 1121BCohort 4 8 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
| 1121BCohort 5 10 mg/kg I.V. once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
| 1121BCohort 6 13 mg/kg once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
| 1121BCohort 7 16 mg/kg once a week for 4 weeks, followed by a 2-week observation period. | Biological | IMC-1121B |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: 6 weeks
Maximum Tolerated Dose
Time frame: 6 weeks
8 secondary outcomes
Maximum concentration (Cmax), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Minimum concentration (Cmin), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Area under concentration (AUC), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Half-life (t 1/2), cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, 5, 6. and 7
Time frame: 6 weeks
Serum Anti-IMC-1121B Antibody Assessment (immunogenicity)
Time frame: 6 weeks
Change in tumor size from Baseline Measurement
Time frame: 6 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.
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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
2 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 Advanced Solid Tumors, run by Eli Lilly and Company at 2 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 10 inclusion and 19 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 2 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: 6 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?
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.