A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01668108
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : February 28, 2018
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH

Brief Summary:

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 or disease

Study Type : Observational
Estimated Enrollment : 800 participants
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.
Study Start Date : August 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

carcinoma, Paclitaxel onkovis (Paclitaxel)
treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.

Primary Outcome Measures :
  1. 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 :
  1. 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
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 Paclitaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Paclitaxel 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): NCT01668108

Contact: K.-U. Seiler, PD Dr. med. +49(0)761479400

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

Responsible Party: Onkovis GmbH Identifier: NCT01668108     History of Changes
Other Study ID Numbers: ONKOPAC 01
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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

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