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Study on Efficacy and Safety of CBLB612 for Neutropenia Prophylaxis

NCT02778763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-07-20

No results posted yet for this study

Summary

Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety of CBLB612 following single administration for neutropenia prophylaxis in breast cancer patients receiving doxorubicin and cyclophosphamide myelosuppressive chemotherapy

Conditions

Interventions

DRUG

CBLB612

4 μg CBLB612 SQ

DRUG

Placebo

Sponsors & Collaborators

  • Cleveland BioLabs, Inc.

    collaborator INDUSTRY

  • BioLab 612 LLC

    lead INDUSTRY

Principal Investigators

  • Sergei A. Tiuliandin, MD PhD · Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences

  • Aleksei G. Manikhas, MD PhD · St.-Petersburg State Budgetary Healtcare Institution "City Clinical Oncological Dispensary"

  • Dmitrii A. Krasnozhon, MD PhD · State Budgetary Healtcare Institution "Leningrad Region Oncological Dispensary"

  • Ruslan M. Paltuev, MD PhD · Non-State Healtcare Institution "Road Clinical Hospital of Open Joint Stock Company Russian Railways"

  • Natalia V. Fadeeva, MD PhD · Federal State Budgetary Healtcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"

  • Roman S. Ponomarev, MD PhD · State Region Budgetary Healtcare Institution "Murmansk Region Oncological Dispensary"

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02778763 on ClinicalTrials.gov