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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Onkovis GmbH
Sponsor:
Collaborator:
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH
ClinicalTrials.gov Identifier:
NCT01614002
First received: June 1, 2012
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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
Carcinoma

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Onkovis GmbH:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Determine the quantity of Doce onkovis needed pro treatment cycle


Secondary Outcome Measures:
  • adverse events during and after treatment [ Time Frame: up to 24 weeks (8 cycles) ] [ Designated as safety issue: Yes ]
    The number and kind of adverse events during and after the intra-venous application of Docetaxel will be assessed and documented.


Estimated Enrollment: 250
Study Start Date: May 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients treated in practices, clinics, hospitals

Criteria

Inclusion Criteria:

  • Indication for Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Docetaxel SmPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614002

Contacts
Contact: K.-U. Seiler, PD Dr. med. +49761479400 info@akp-freiburg.de

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

No publications provided

Responsible Party: Onkovis GmbH
ClinicalTrials.gov Identifier: NCT01614002     History of Changes
Other Study ID Numbers: ONKODOC 01
Study First Received: June 1, 2012
Last Updated: October 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Onkovis GmbH:
carcinoma
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
Docetaxel
Doce onkovis
Quantity of Docetaxel
Packaging Sizes

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014