Carcinoma Clinical Trial
Official title:
Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
| NCT number | NCT01840280 |
| Other study ID # | ONKOIRI01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2013 |
| Est. completion date | April 2018 |
| Verified date | May 2018 |
| Source | Onkovis GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 324 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Indication for Irinotecan according to the SmPC and treating physician Exclusion Criteria: - according to the Irinotecan SmPC |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Practice | Elstra | |
| Germany | Practice | Leipzig | |
| Germany | Practice | Naunhof | |
| Germany | Practice | Neustadt/Sachsen | |
| Germany | Practice | Werdau |
| Lead Sponsor | Collaborator |
|---|---|
| Onkovis GmbH | AKP Freiburg GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Quantity of Irinotecan onkovis needed per treatment cycle | Determine the quantity of Irinotecan onkovis needed pro treatment cycle | up to 24 weeks | |
| Secondary | Adverse events during and after treatment | The number and kind of adverse events during and after the intra-venous application of Irinotecan will be assessed and documented. | up to 24 weeks |
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