drugset / Trial / NCT02115984
Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with distant metastases).
Timeline
- Start
- 2010-05
- Primary completion
- 2012-05
- Completion
- 2012-05
Publications
- Proskurina AS, Gvozdeva TS, Potter EA, Dolgova EV, Orishchenko KE, Nikolin VP, Popova NA, Sidorov SV, Chernykh ER, Ostanin AA, Leplina OY, Dvornichenko VV, Ponomarenko DM, Soldatova GS, Varaksin NA, Ryabicheva TG, Uchakin PN, Rogachev VA, Shurdov MA, Bogachev SS. Five-year disease-free survival among stage II-IV breast cancer patients receiving FAC and AC chemotherapy in phase II clinical trials of Panagen. BMC Cancer. 2016 Aug 18;16:651. doi: 10.1186/s12885-016-2711-5.
- Proskurina AS, Gvozdeva TS, Alyamkina EA, Dolgova EV, Orishchenko KE, Nikolin VP, Popova NA, Sidorov SV, Chernykh ER, Ostanin AA, Leplina OY, Dvornichenko VV, Ponomarenko DM, Soldatova GS, Varaksin NA, Ryabicheva TG, Uchakin PN, Zagrebelniy SN, Rogachev VA, Bogachev SS, Shurdov MA. Results of multicenter double-blind placebo-controlled phase II clinical trial of Panagen preparation to evaluate its leukostimulatory activity and formation of the adaptive immune response in patients with stage II-IV breast cancer. BMC Cancer. 2015 Mar 13;15:122. doi: 10.1186/s12885-015-1142-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panagen | Other / unclassified | 30 mg | Oral |