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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01614002
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : June 4, 2015
AKP Freiburg GmbH
Information provided by (Responsible Party):
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.

Condition or disease

Study Type : Observational
Actual Enrollment : 371 participants
Time Perspective: Prospective
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.
Study Start Date : May 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated in practices, clinics, hospitals

Inclusion Criteria:

  • Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Docetaxel SmPC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01614002

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

Responsible Party: Onkovis GmbH Identifier: NCT01614002     History of Changes
Other Study ID Numbers: ONKODOC 01
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Onkovis GmbH:
breast cancer
non-small cell lung cancer
prostata cancer
adenocarcinoma of the stomach
squamous cell carcinoma of the head and neck region
ambulant chemotherapy
treatment cycles
Doce onkovis
Quantity of Docetaxel
Packaging Sizes

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action