Trial Profile

A Pharmacokinetic Phase I study Comparing Docecal and Taxotere in Patients with Metastatic Breast Cancer

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 20 Apr 2023

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At a glance

Drugs Docetaxel (Primary)
Indications Advanced breast cancer
Focus Pharmacokinetics; Registrational
Sponsors Vivesto

Most Recent Events

31 May 2020 Results assessing PK, safety and early activity from two clinical studies: EudraCT2012-005161-12 and EudraCT2013-004889-33 presented at the 56th Annual Meeting of the American Society of Clinical Oncology
24 Jun 2019 According to an Oasmia Pharmaceutical media release, this study indicates that Docecal is bioequivalent with Taxotere (AUC0-last and Cmax) with regards to the total fraction of docetaxel in plasma.
24 Jun 2019 Results from the two clinical studies using Docecal in patients with metastatic breast cancer (CTP 293315 and CTP 293313) presented in an Oasmia Pharmaceutical media release.

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