Trials / Unknown
UnknownNCT04905329
A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 285 (estimated)
- Sponsor
- Moscow Clinical Scientific Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies
Conditions
- Solid Tumor
- High-Risk Cancer
- Breast Cancer
- Gastrointestinal Cancer
- Gynecological Malignancies
- Myelosuppression
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empegfilgrastim | Extimia® |
Timeline
- Start date
- 2020-04-28
- Primary completion
- 2022-12-31
- Completion
- 2023-09-01
- First posted
- 2021-05-27
- Last updated
- 2021-06-02
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04905329. Inclusion in this directory is not an endorsement.