Study on Efficacy and Safety of CBLB612 for Neutropenia Prophylaxis

NCT02778763 | Completed Phase 2

• 1 other identifier: BL-612-BC1
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer

Keywords

Breast cancer; TLR2; Neutropenia

Outcome Measures

Primary Outcomes (6)

• Duration of ANC <1.0 x 103/μl (Grade 3-4)

  Baseline to up to 38 days after the 1st drug administration

• Duration of ANC <0.5 x 103/μl (Grade 4)

  Baseline to up to 38 days after the 1st drug administration

• Maximum level of ANC decrease (nadir)

  Baseline to up to 38 days after the 1st drug administration

• Time to recovery of ANC level ≥1.5 x 103/μl

  Baseline to up to 38 days after the 1st drug administration

• Incidence of febrile neutropenia (simultaneous drop of ANC <0.5 x 103/μl and body temperature >38.0°C)

  Baseline to up to 38 days after the 1st drug administration

• Safety evaluation as measured by treatment-related adverse events as assessed by CTCAE v4.0

  Baseline to up to 38 days after the 1st drug administration

Secondary Outcomes (8)

• Duration of thrombocytopenia <50 x 103/μl

  Baseline to up to 38 days after the 1st drug administration

• Duration of thrombocytopenia <25 x 103/μl

  Baseline to up to 38 days after the 1st drug administration

• Duration of thrombocytopenia <10 x 103/μl

  Baseline to up to 38 days after the 1st drug administration

• Maximum decrease of platelet level (nadir)

  Baseline to up to 38 days after the 1st drug administration

• Time to platelet level recovery ≥75 x 103/μl

  Baseline to up to 38 days after the 1st drug administration

Study Arms (3)

One injection of CBLB612 after Сhemo

EXPERIMENTAL

One injection of placebo at Day -2 (48 hours prior AC chemotherapy treatment) and one injection of 4 μg CBLB612 at Day 1 (24 hours after AC chemotherapy treatment)

Drug: CBLB612; Drug: Placebo

One injection of CBLB612 prior Сhemo

EXPERIMENTAL

One injection of 4 μg CBLB612 at Day -2 (48 hours prior AC chemotherapy treatment) and one injection of placebo at Day 1 (24 hours after AC chemotherapy treatment)

Drug: CBLB612; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Two injections of placebo at Day -2 and Day 1 (48 hours prior and 24 hours after AC chemotherapy treatment)

Drug: Placebo

Interventions

CBLB612 DRUG

4 μg CBLB612 SQ

One injection of CBLB612 after Сhemo; One injection of CBLB612 prior Сhemo

Placebo DRUG

Also known as: PBS, Phosphate buffer saline

One injection of CBLB612 after Сhemo; One injection of CBLB612 prior Сhemo; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent for the study participation.
• Women in the age above 18 years inclusively.
• Patients with histologically proven diagnosis of breast cancer to which the 1-st cycle of AC chemotherapy treatment is indicated (with 3-week interval).
• ECOG Performance Status of 0-2.
• Life expectancy ≥ 6 months.
• Completion of all previous cancer therapies (including surgery, radiotherapy, chemotherapy, immunotherapy or study therapy) not later than 4 weeks prior the CBLB612 study.
• All acute toxic effects of any previous therapies \<Grade 1 prior the study, except for alopecia and/or neurotoxicity (Grade 1 or 2 is allowed).
• Adequate hematopoiesis function:
• WBC ≥3.0 x 103/μl;
• PTT ≥1.5 x 103/μl;
• Platelets ≥75 x 103/μl;
• Hemoglobin ≥10 g/dl.
• Adequate hepatic function:
• Total bilirubin ≤1.5 x ULN;
• ALT and AST ≤3 x ULN;

You may not qualify if:

• Rapidly progressing, clinically unstable breast cancer with present clinical signs of cerebral or meningeal membrane metastases.
• Specific contraindications or hypersensitivity data in relation to any of the following drugs: doxorubicin, cyclophosphamide, CBLB612, anti-emetic agents (aprepitant, palonosetron), anti-inflammatory drugs (including paracetamol and aspirin), as well excipients of the abovementioned drug agents including polysorbate 80.
• History of febrile neutropenia.
• Presence of autoimmune disease.
• Acute or chronic/relapsing inflammatory eye disease or any other significant eye disorder.
• patients with mild and moderate myopia or hypermetropia, or presbyopia may be enrolled to the study.
• Pregnancy or breast feeding, refusal to use adequate contraception methods during the study.
• Signs of ongoing systemic bacterial, fungal or viral infectious disease or local infection requiring treatment at the randomization.
• patients with local fungal lesion of skin area or nail may be enrolled to the study.
• Systemic antibiotic therapy during up to 72 hours prior the randomization.
• Previous radiotherapy of ≥30% of bone marrow.
• Surgery or chemotherapy or experimental drug therapy within 4 weeks prior randomization.
• Transplantation of bone marrow or peripheral blood precursor cells.
• Intake of more than 10 portions of alcoholic beverages per week or anamnestic data on alcoholism, narcomania, drug abuse.
• one portion of alcoholic beverage is 250 ml of beer, 125 ml of wine or 30 ml of strong alcoholic beverage.

Sponsors & Collaborators

• BioLab 612 LLC: lead
• Cleveland BioLabs, Inc.: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Aleksei G. Manikhas, MD PhD

  St.-Petersburg State Budgetary Healtcare Institution "City Clinical Oncological Dispensary"

  PRINCIPAL INVESTIGATOR

• Dmitrii A. Krasnozhon, MD PhD

  State Budgetary Healtcare Institution "Leningrad Region Oncological Dispensary"

  PRINCIPAL INVESTIGATOR

• Ruslan M. Paltuev, MD PhD

  Non-State Healtcare Institution "Road Clinical Hospital of Open Joint Stock Company Russian Railways"

  PRINCIPAL INVESTIGATOR

• Natalia V. Fadeeva, MD PhD

  Federal State Budgetary Healtcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"

  PRINCIPAL INVESTIGATOR

• Roman S. Ponomarev, MD PhD

  State Region Budgetary Healtcare Institution "Murmansk Region Oncological Dispensary"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: May 20, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07