Clinical Trial: A Study of IMC-A12 in Islet Cell Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Multicenter, Two Tier Study of IMC-A12 in Combination With Depot Octreotide in Patients With Metastatic, Well or Moderately Differentiated Carcinoid or Islet Cell Carc
Brief Summary: Determine the 6-month progression free survival (PFS) rate associated with IMC-A12 in combination with depot octreotide acetate (octreotide) in patients with metastatic neuroendocrine tumors.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Progression-free survival (PFS) [ Time Frame: Approximately 6 months ]
Original Primary Outcome: To determine the 6-month progression-free survival (PFS) rate associated with IMC-A12 in combination with depot octreotide acetate (octreotide) in patients with metastatic neuroendocrine tumors. [ Time Frame: 6 months ]
Current Secondary Outcome:
- Objective response rate (ORR) [ Time Frame: Approximately 18 months ]
- Biochemical response rate [ Time Frame: Approximately 18 months ]Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid , chromogranin A, ACTH, or gastrin) in the subset of patients with biochemically measurable disease.
- Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (AEs) [ Time Frame: Approximately 18 months ]
- Maximum concentration (Cmax) prior to day 1 [ Time Frame: Day 1 ]Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma prior to receiving study drug.
- Half-life (t 1/2) prior to day 1 [ Time Frame: Day 1 ]Half-life (t 1/2) is the maximum peak concentration measured in blood plasma prior to receiving study drug.
- Area under concentration (AUCinf) prior to day 1 [ Time Frame: Day 1 ]Area under concentration (AUCinf) is the area under serum concentration versus time curve from time zero extrapolated to infinity prior to receiving study drug.
- Clearance (CL) prior to day 1 [ Time Frame: Day 1 ]
- Volume at steady state (Vss) prior to day 1 [ Time Frame: Day 1 ]
- Serum Anti-IMC-A12 Antibody Assessment [ Time Frame: Approximately 18 months ]
- Effect of IMC-A12 in combination with depot octreotide on selected pharmacodynamic markers; concentration of IGF-I, IGF-II, IGFBF-1 and IGFBF-2 [ Time Frame: Approximately 18 months ]
Original Secondary Outcome:
- To determine the modified objective response rate (ORR) in patients with radiographically measurable disease [ Time Frame: 18 months or until patients progress ]
- Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid , chromogranin A, ACTH, or gastrin) in the subset of patients with biochemically measurable disease. [ Time Frame: 18 months or until patients progress ]
- To evaluate the safety, tolerability, and adverse event profile of IMC-A12 in combination with depot octreotide [ Time Frame: 18 months or until patients progress ]
- To evaluate the pharmacokinetic profile of IMC-A12 [ Time Frame: 18 months or until patients progress ]
- To screen for the development of antibodies against IMC-A12 [ Time Frame: 18 months or until patients progress ]
- To evaluate the effect of IMC-A12 in combination with depot octreotide on selected pharmacodynamic markers [ Time Frame: 18 months or until patients progress ]
Information By: Eli Lilly and Company
Dates:
Date Received: October 27, 2008
Date Started: February 2009
Date Completion:
Last Updated: August 12, 2016
Last Verified: August 2016