Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01320020
Brief Summary:
The study is designed as an open-label dose-escalation study to investigate the safety and tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4 single i.v. administrations of catumaxomab followed by 1 week for safety observations after each administration. All patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first.
Detailed Description:
Epithelial cancer patients who are progressing on or after standard therapy or for whom no standard therapy exists. Catumaxomab (trifunctional anti-EpCAM x anti-CD3 antibody)Catumaxomab will be administered i.v. once weekly (qwk) with each infusion lasting for 6 hours. The starting dose for catumaxomab will be 2 µg. The dose escalation schedule is based on a Modified Fibonacci Schedule with the following dose cohorts: 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose. Subsequent dose levels will correspond to dosing increments of about 30%, e.g. 25, 33, 43, 56 µg. After completion of the DLT period, all patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first. The maximum length of treatment, however, will be restricted to an additional 12 weeks after the DLT period - resulting in a maximum treatment duration of 16 weeks total.
Study:
NCT01320020
Study Brief:
Protocol Section:
NCT01320020