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

Carcinoma Clinical Trial

Official title:

Open, Multicenter Observational Study of Docetaxel Utilized in Mono- or Combination Therapy for Treatment of Breast Cancer, NSCLC, Prostate Carcinoma, Adenocarcinoma of Stomach and Advanced Squamous Cell Carcinoma of Head/Neck Region.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614002
• Other study ID #: ONKODOC 01
• Status: Completed
• Phase: N/A
• First received: June 1, 2012
• Last updated: June 3, 2015
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Onkovis GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

• according to the Docetaxel SmPC

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell

Locations

Country	Name	City	State
Germany	Practice	Berlin
Germany	Practice	Brandenburg
Germany	Practice	Chemnitz
Germany	Practice	Cottbus
Germany	Practice	Dresden
Germany	Practice	Elstra
Germany	Practice	Freital
Germany	Practice	Fürstenwalde
Germany	Practice	Halle/Saale
Germany	Practice	Köthen
Germany	Practice	Kronach
Germany	Hospital	Leipzig
Germany	Practice	Leipzig
Germany	Practice	Magdeburg
Germany	Practice	Meiningen
Germany	Practice	Mühlhausen
Germany	Practice	Parchim
Germany	Practice	Plauen
Germany	Practice	Scheibenberg
Germany	Clinic	Torgau
Germany	Practice	Werdau
Germany	Practice	Zittau
Germany	Practice	Zwickau

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 Doce onkovis needed pro treatment cycle	Determine 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).	No
Secondary	adverse events during and after treatment	The number and kind of adverse events during and after the intra-venous application of Docetaxel will be assessed and documented.	up to 24 weeks (8 cycles)	Yes