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:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT00364195
Brief Summary:
This is a Phase II study designed to evaluate whether the co-administration of a fixed dose of tesmilifene and a standard regimen of docetaxel alters the plasma pharmacokinetics of docetaxel. This study will also assess the safety and efficacy of the tesmilifene/docetaxel combination in metastatic breast cancer patients.
Detailed Description:
Primary Objective:
1\. To evaluate whether the co-administration of a fixed dose of tesmilifene (5.3 mg/kg) with a standard dose of docetaxel (100 mg/m2) alters the plasma pharmacokinetics of docetaxel compared to the pharmacokinetics of docetaxel when given alone.
Secondary Objectives:
1. To correlate plasma tesmilifene levels during and following the infusion with the acute tesmilifene-related adverse events observed during and after the infusion.
2. To collect safety information for tesmilifene when administered in combination with docetaxel.
3. To evaluate response rate, duration of response and overall survival in metastatic breast cancer patients receiving docetaxel plus tesmilifene.
Study:
NCT00364195
Study Brief:
Protocol Section:
NCT00364195