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

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ClinicalTrials.gov Identifier: NCT01840280
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH

Brief Summary:

The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.


Condition or disease
Carcinoma

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Study Type : Observational
Actual Enrollment : 324 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
Actual Study Start Date : April 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Carcinoma, Irinotecan onkovis (Irinotecan)
Treatment in mono- or combination therapy with Irinotecan of advanced colorectal carcinoma.



Primary Outcome Measures :
  1. The Quantity of Irinotecan onkovis needed per treatment cycle [ Time Frame: up to 24 weeks ]
    Determine the quantity of Irinotecan onkovis needed pro treatment cycle


Secondary Outcome Measures :
  1. Adverse events during and after treatment [ Time Frame: up to 24 weeks ]
    The number and kind of adverse events during and after the intra-venous application of Irinotecan will be assessed and documented.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Indication for Irinotecan according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Irinotecan 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 ClinicalTrials.gov identifier (NCT number): NCT01840280


Locations
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Germany
Practice
Elstra, Germany, 01920
Practice
Leipzig, Germany, 04179
Practice
Naunhof, Germany, 04683
Practice
Neustadt/Sachsen, Germany, 01844
Practice
Werdau, Germany, 08412
Sponsors and Collaborators
Onkovis GmbH
AKP Freiburg GmbH

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Responsible Party: Onkovis GmbH
ClinicalTrials.gov Identifier: NCT01840280     History of Changes
Other Study ID Numbers: ONKOIRI01
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Keywords provided by Onkovis GmbH:
carcinoma
colorectal cancer
ambulant chemotherapy
treatment cycles
Irinotecan
Irinotecan onkovis
Quantity of Irinotecan
Packaging Sizes
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents