Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Participants will receive cixutumumab IV 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.
ImClone Investigational Site
Los Angeles, California, United States
ImClone Investigational Site
Los Angeles, California, United States
ImClone Investigational Site
Aurora, Colorado, United States
Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months
Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.
Time frame: From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)
Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)
Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.
Time frame: From Start of Treatment Baseline to Disease Progression (Up to 18 Months)
Percentage of Participants With a Biochemical Response Rate
Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ImClone Investigational Site
Atlanta, Georgia, United States
ImClone Investigational Site
Indianapolis, Indiana, United States
ImClone Investigational Site
Kenner, Louisiana, United States
ImClone Investigational Site
Columbus, Ohio, United States
ImClone Investigational Site
Providence, Rhode Island, United States
ImClone Investigational Site
Nashville, Tennessee, United States
ImClone Investigational Site
Dallas, Texas, United States
Time frame: From Start of Treatment Up to 18 Months
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time frame: 18 months
Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1
Time frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Half-life (t 1/2) Cycle 1
Time frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Area Under Concentration (AUCinf) Cycle 1
Time frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Clearance (CL) Cycle 1
Time frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
PK: Volume at Steady State (Vss) Cycle 1
Time frame: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion
Serum Anti-Cixutumumab Antibody Assessment
Time frame: 18 months
Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2
Time frame: 18 months