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

Carcinoma Clinical Trial

Official title:

Open, Multicenter Observational Study of Paclitaxel Utilized in Mono- or Combination Therapy for the Treatment of Breast Cancer, Non-small Cell Lung Cancer and Ovarial Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668108
• Other study ID #: ONKOPAC 01
• Status: Completed
• Start date: August 2012
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Onkovis GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel 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 survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Indication for Paclitaxel according to the SmPC and treating physician

Exclusion Criteria:

• according to the Paclitaxel SmPC

Related Conditions & MeSH terms

• Carcinoma

Locations

Country	Name	City	State
Germany	Practice	Brandenburg
Germany	Practice	Chemnitz
Germany	Practice	Dresden
Germany	Practice	Mühlhausen
Germany	Practice	Plauen

Sponsors (2)

Lead Sponsor	Collaborator
Onkovis GmbH	AKP Freiburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quantity of Paclitaxel onkovis needed pro treatment cycle	Determine the quantity of Paclitaxel 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).
Secondary	adverse events during and after treatment in comparison to Docetaxel onkovis	The number and kind of adverse events during and after the intra-venous application of Paclitaxel will be assessed, documented and compared to those of Docetaxel.	up to 24 weeks (8 cycles)