Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors
The participant has metastatic disease at the time of study entry
The participant must have a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, measurable by elevated tumor markers (eg, 24-hour urine 5-HIAA, chromogranin A, adrenocorticotropin hormone (ACTH), gastrin, or other tumor specific biochemical markers), or both
The participant is age ≥ 18 years
The participant's tumor has Ki-67 expression ≤ 20%
The participant is receiving depot octreotide therapy at the time of enrolling into the study
The participant has received 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatments
The participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy
The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide
The participant has completed prior chemotherapy and/or radiotherapy with curative intent at least 3 weeks prior to the administration of the first dose of study therapy. Participants that have received palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible
The participant has a life expectancy of \> 3 months
The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
The participant has adequate hematologic function as defined by absolute neutrophil count ≥ 1500/microliters (μL), hemoglobin ≥ 9 gram/deciliter (g/dL), and platelet count ≥100,000/μL
The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x the ULN (or ≤ 5 x the ULN in the presence of known liver metastases)
The participant either has adequate coagulation function as defined by international normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) no more than 5 seconds above the ULN, or is on a stable dose of anticoagulant
The participant has adequate renal function as defined by serum creatinine ≤ 1.5 x the institutional ULN or creatinine clearance ≥ 60 milliliter/minute (mL/min) for participants with creatinine levels above the ULN
The participant has fasting serum glucose \< 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)≤ 7. If baseline nonfasting glucose is \< 160 mg/dL, fasting glucose measurement is not required
Because the teratogenicity of cixutumumab is not known, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
The participant has the ability to understand and the willingness to sign a written informed consent document
You may not be if
The participant has uncontrolled brain or leptomeningeal metastases
The participant has not recovered to Grade ≤ 1 from adverse events due to agents administered more than 4 weeks prior to study entry (except for alopecia)
The participant is receiving any other investigational agent(s)
The participant has received therapeutic radiolabeled somatostatin analogues
The participant has received more than 2 prior regimens of systemic therapy in the metastatic setting
The participant has a history of treatment with other agents targeting the IGF receptor
The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of cixutumumab or to octreotide
The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their fasting glucose \< 160 mg/dL or below the ULN and that they are on a stable dietary or therapeutic regimen for this condition
The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
The participant is pregnant or lactating
The participant is known to be positive for infection with the human immunodeficiency virus
The participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected or treated with no known active disease present and no treatment administered for the last 3 years
Clareo Health | A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer
