A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer
This study is currently recruiting participants.
Verified August 2012 by Onkovis GmbH
Sponsor:
Onkovis GmbH
Collaborator:
AKP Freiburg GmbH (Clinical Research Organization)
Information provided by (Responsible Party):
Onkovis GmbH
ClinicalTrials.gov Identifier:
NCT01668108
First received: August 15, 2012
Last updated: August 17, 2012
Last verified: August 2012
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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: | 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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Paclitaxel
U.S. FDA Resources
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). ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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: | July 2014 |
| Groups/Cohorts |
|---|
|
carcinoma, Paclitaxel onkovis (Paclitaxel)
treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.
|
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 Paclitaxel according to the SmPC and treating physician
Exclusion Criteria:
- according to the Paclitaxel SmPC
Contacts and Locations
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 (Clinical Research Organization)
More Information
No publications provided
| 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: | August 17, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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:
|
Breast Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013