WHO ICTRP trial
A Phase III Randomized, Double-Blind, Active-Controlled Clinical Trial to Study…
EUCTR2011-003399-36-LV · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2011-003399-36-LV |
|---|---|
| Public title | A Phase III Randomized, Double-Blind, Active-Controlled Clinical Trial to Study the Efficacy and Safety of MK-4214 (filgrastim) and Neupogen™ as an Adjunct to Combination Chemotherapy with Doxorubicin and Docetaxel in Breast Cancer Patients |
| Scientific title | A Phase III Randomized, Double-Blind, Active-Controlled Clinical Trial to Study the Efficacy and Safety of MK-4214 (filgrastim) and Neupogen™ as an Adjunct to Combination Chemotherapy with Doxorubicin and Docetaxel in Breast Cancer Patients |
| Primary sponsor | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Serbia;Belarus;Philippines;Ukraine;Lithuania;Russian Federation;Chile;Italy;India;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Brazil;Romania;Croatia;Peru;Georgia;South… |
| Conditions | Breast Cancer MedDRA version: 14.0 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT… |
| Interventions | Product Name: Filgrastim Product Code: MK-4214 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Filgrastim Current Sponsor code: MK-4214 Other descriptive name: Recombinant human granulocyte… |
| Registration date | Aug 25, 2011 |
| Target size | 350 |
| Secondary IDs | MK-4214-008 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: