A Study of IMC-A12 Every 2 Weeks in Patients With Tumors Who No Longer Respond to Treatment or No Treatment is Available
NCT ID: NCT00785941
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2006-04-30
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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IMC-A12
All patients will receive intravenous infusions of IMC-A12, with the dose depending on which cohort they are enrolled into a minimum of three patients will be enrolled in each Cohort. When all patients complete a cohort, dose escalation to the next Cohort will occur.
A treatment cycle will consist of IMC-A12 administered intravenously, once every other week for 4 weeks, for a total of 2 doses; followed by a 2-week observation period.
IMC-A12
Cohort 1
6 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 2
10 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 3
15 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 4
21 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 5
27 mg/kg I.V., once every other week for 4 weeks
Interventions
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IMC-A12
Cohort 1
6 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 2
10 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 3
15 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 4
21 mg/kg I.V., once every other week for 4 weeks
IMC-A12
Cohort 5
27 mg/kg I.V., once every other week for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A life expectancy of \>3 months
* Adequate hematologic function
* Adequate hepatic function
* Adequate renal function
* Use of effective contraception, if procreative potential exists.
* At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, prior radiation therapy (palliative radiation therapy is allowed), an open biopsy, or a significant traumatic injury to allow for adequate recovery
* At least 6 weeks must have elapsed from nitrosoureas, mitomycin C, or monoclonal antibody therapy to allow for adequate recovery
* Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
Exclusion Criteria
* Uncontrolled intercurrent illness including, but not limited to:
* ongoing or active infection requiring parenteral antibiotics
* 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 \[National Cancer Institute {NCI}-Common Terminology Criteria for Adverse Events {CTCAE}, Version 3.0, grade 3\] or asymptomatic sustained ventricular tachycardia)
* 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 be clinically stable and not taking steroids; anticonvulsants are allowed)
* A serious or nonhealing active wound, ulcer, or bone fracture
* Known human immunodeficiency virus-positive
* A history of a hemorrhagic or thrombotic disorder within 9 months
* Pregnant or breast feeding
* A history of prior treatment with other agents specifically targeting IGFRs.
* Known diabetes
* Inability or unwillingness to interrupt steroidal or hormonal therapy for the duration of treatment with IMC-A12
* A positive anti-IMC-A12 antibody response
* A 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 of the employees
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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E-mail: ClinicalTrials@ ImClone.com
Role: STUDY_CHAIR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Nashville, Tennessee, United States
Countries
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References
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Higano CS, Berlin J, Gordon M, LoRusso P, Tang S, Dontabhaktuni A, Schwartz JD, Cosaert J, Mehnert JM. Safety, tolerability, and pharmacokinetics of single and multiple doses of intravenous cixutumumab (IMC-A12), an inhibitor of the insulin-like growth factor-I receptor, administered weekly or every 2 weeks in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):450-62. doi: 10.1007/s10637-015-0217-7. Epub 2015 Mar 7.
Other Identifiers
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CP13-0502
Identifier Type: OTHER
Identifier Source: secondary_id
I5A-IE-JAEI
Identifier Type: OTHER
Identifier Source: secondary_id
13933
Identifier Type: -
Identifier Source: org_study_id