A Non Interventional Study With Doce Onkovis (Docetaxel) Utilized for the Treatment of Cancer

Completed

• Conditions: Carcinoma

• Registration Number: NCT01614002
• Lead Sponsor: Onkovis GmbH

Brief Summary

The main purpose of this observational study with Docetaxel is to determine the number of treatment cycles and the quantity of Doce onkovis needed therefore under the special circumstance of ambulant chemotherapy.

onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.

Secondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To this purpose data regarding co medications and adverse events are also collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

Inclusion Criteria

• Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria

• according to the Docetaxel SmPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the quantity of Doce onkovis needed pro treatment cycle	the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).	Determine the quantity of Doce onkovis needed pro treatment cycle

Secondary Outcome Measures

Name	Time	Method
adverse events during and after treatment	up to 24 weeks (8 cycles)	The number and kind of adverse events during and after the intra-venous application of Docetaxel will be assessed and documented.

Trial Locations

Locations (3)

Hospital; 🇩🇪 Leipzig, Germany

Clinic; 🇩🇪 Torgau, Germany

Practice; 🇩🇪 Zwickau, Germany