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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Onkovis GmbH
Sponsor:
Collaborator:
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH
ClinicalTrials.gov Identifier:
NCT01668108
First received: August 15, 2012
Last updated: February 22, 2017
Last verified: February 2017
  Purpose

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.


Condition
Carcinoma

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Onkovis GmbH:

Primary Outcome Measures:
  • the quantity of Paclitaxel 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 Paclitaxel onkovis needed pro treatment cycle


Secondary Outcome Measures:
  • adverse events during and after treatment in comparison to Docetaxel onkovis [ Time Frame: up to 24 weeks (8 cycles) ]
    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.


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
carcinoma, Paclitaxel onkovis (Paclitaxel)
treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.

  Eligibility

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
Criteria

Inclusion Criteria:

  • Indication for Paclitaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Paclitaxel 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: NCT01668108

Contacts
Contact: K.-U. Seiler, PD Dr. med. +49(0)761479400 info@akp-freiburg.de

Locations
Germany
Practice Recruiting
Brandenburg, Germany, 14770
Practice Recruiting
Chemnitz, Germany, 09117
Practice Recruiting
Dresden, Germany, 01307
Practice Recruiting
Mühlhausen, Germany, 99974
Practice Recruiting
Plauen, Germany, 08525
Sponsors and Collaborators
Onkovis GmbH
AKP Freiburg GmbH
  More Information

Responsible Party: Onkovis GmbH
ClinicalTrials.gov Identifier: NCT01668108     History of Changes
Other Study ID Numbers: ONKOPAC 01
Study First Received: August 15, 2012
Last Updated: February 22, 2017

Keywords provided by Onkovis GmbH:
carcinoma
breast cancer
non-small cell lung cancer
ovarial cancer
ambulant chemotherapy
treatment cycles
Paclitaxel
Paclitaxel onkovis
Quantity of Paclitaxel
Packaging Sizes

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2017