Study of IMC-11F8 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title: A Phase 1 Study of IMC-11F8 in Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

This study is to establish the safety and pharmacokinetic (PK) profile of IMC-11F8, administered either: (1) in a 3-week cycle; or (2) in a 2-week cycle to Japanese patients with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available.

Clinical Trial Description

This single center, open-label, single-arm, Phase 1 study will enroll 18 patients at a maximum. The actual size will vary depending on the dose-limiting toxicities (DLTs) observed and the resultant sizes of the cohorts. Patients will receive IMC-11F8 administered intravenously, once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). All infusions can be administered within ± 1 day of the scheduled administration date. After one cycle of treatment, patients who have an objective response or stable disease may continue to receive IMC-11F8 at the same dose and schedule until disease progression or other withdrawal criteria are met.

A minimum of three patients will be enrolled in each cohort. Dose escalation in successive cohorts will occur once all patients complete one cycle of therapy.

Patients will be enrolled sequentially into each cohort. A completed patient will be either a patient who completes the initial 6 week treatment period (Cycle 1) or a patient who discontinues therapy for an IMC-11F8-related toxicity during Cycle 1. Patients who do not complete the first 6 weeks of treatment for reasons other than an IMC-11F8-related toxicity will be replaced. Toxicity data for each cohort will be reviewed prior to dose escalation. Upon completion of all required safety evaluations during the initial 6 weeks, the next cohort of new patients will be treated at the next higher dose level using a dose escalation scheme. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

• NCT number: NCT01088464
• Study type: Interventional
• Source: Eli Lilly and Company
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Completion date: February 2012