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

June 3, 2015 updated by: Onkovis GmbH

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13156
        • Practice
      • Brandenburg, Germany, 14770
        • Practice
      • Chemnitz, Germany, 09117
        • Practice
      • Cottbus, Germany, 03055
        • Practice
      • Dresden, Germany, 01307
        • Practice
      • Elstra, Germany, 01920
        • Practice
      • Freital, Germany, 01705
        • Practice
      • Fürstenwalde, Germany, 15517
        • Practice
      • Halle/Saale, Germany, 06132
        • Practice
      • Kronach, Germany, 96317
        • Practice
      • Köthen, Germany, 06366
        • Practice
      • Leipzig, Germany, 04277
        • Practice
      • Leipzig, Germany, 04277
        • Hospital
      • Magdeburg, Germany, 39104
        • Practice
      • Meiningen, Germany, 98617
        • Practice
      • Mühlhausen, Germany, 99974
        • Practice
      • Parchim, Germany, 19370
        • Practice
      • Plauen, Germany, 08525
        • Practice
      • Scheibenberg, Germany, 09481
        • Practice
      • Torgau, Germany, 04860
        • Clinic
      • Werdau, Germany, 08412
        • Practice
      • Zittau, Germany, 02763
        • Practice
      • Zwickau, Germany, 08060
        • Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated in practices, clinics, hospitals

Description

Inclusion Criteria:

  • Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Docetaxel SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
carcinoma, Doce onkovis (Docetaxel)
treatment in mono- or combination therapy with Docetaxel of breast cancer, non-small cell lung cancer, prostata carcinoma, adenocarcinoma of the stomach and advanced squamous cell carcinoma of the head/neck region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the quantity of Doce onkovis needed pro treatment cycle
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events during and after treatment
Time Frame: 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.
up to 24 weeks (8 cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onkovis GmbH

Collaborators

AKP Freiburg GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONKODOC 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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