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Breast CancerPhase 2NCT02778763

Study on Efficacy and Safety of CBLB612 for Neutropenia Prophylaxis

A Phase 2 study testing CBLB612 in people with Breast Cancer, run by BioLab 612 LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
CBLB612
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
No sites listed yet
Study dates
Dec 2015to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • Alkaline phosphatase ≤2.5 x ULN.
  • Adequate renal function:
  • Creatinine ≤1.5 x ULN.
  • Adequate values of hemostasis system:
  • Prothrombin time;
  • ≤1.5 x ULN;
  • Activated partial thromboplastin time ≤1.5 x ULN;
  • INR ≤1.5 x ULN.
  • Adequate cardiac function which means
  • LVEF ≥45 based on ultrasonic examination of the heart or radionuclide angiography;
  • 12-lead electrocardiogram (ECG) with normal tracing, non-clinically significant changes may occur that do not require medical intervention.
  • Negative test for serological infection markers:
  • Negative HIV-antibody test;
  • Negative test for hepatitis B surface antigen (HBsAg);
  • Negative test for hepatitis C virus antibodies or negative test for mRNA of hepatitis C virus;
  • Negative test for Treponema pallidum antibodies.
  • Negative pregnancy test.
  • Consent of a patient with preserved reproductive function to use effective contraception method since screening up to at least 3 months after the study therapy.
  • e.g. intrauterine device, oral contraceptive, subcutaneous implant or double-barrier method (condom with contraceptive sponge or contraceptive vaginal suppository).
  • A patient shall be ready and able to meet the requirements of the study protocol and have the opportunity to participate in the study throughout the scheduled period.

Who cannot join

  • 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.
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  • 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.
  • Current immunosuppressant therapy including systemic corticosteroid therapy.
  • Clinically significant abnormal vital signs, results of laboratory and instrumental tests, based on the investigator assessment.
  • Any disease, condition, organ dysfunction or central nervous system disorder of the intake of narcotic drugs which, according to the investigator, may affect ability to participate in the study or hinder assessment of study results.

About this study

Official title: 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

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
Being tested
CBLB612, Placebo
Keywords
Breast cancer, TLR2, Neutropenia
Medical subject headings
Breast Neoplasms, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBLB612Drug

    4 μg CBLB612 SQ

  • PlaceboDrug

    Also called PBS, Phosphate buffer saline

Study groups in NCT02778763
Study groupRoleWhat they receive
One injection of CBLB612 after СhemoExperimentalOne 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)
Receives: Drug: CBLB612; Drug: Placebo
One injection of CBLB612 prior СhemoExperimentalOne 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)
Receives: Drug: CBLB612; Drug: Placebo
PlaceboPlacebo comparatorTwo injections of placebo at Day -2 and Day 1 (48 hours prior and 24 hours after AC chemotherapy treatment)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

  3. Maximum level of ANC decrease (nadir)

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

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

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

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

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

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

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

Secondary outcomes (8)

  1. Duration of thrombocytopenia <50 x 103/μl

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

  2. Duration of thrombocytopenia <25 x 103/μl

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

  3. Duration of thrombocytopenia <10 x 103/μl

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

  4. Maximum decrease of platelet level (nadir)

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

  5. Time to platelet level recovery ≥75 x 103/μl

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

  6. Changes in comparison with baseline level CD34+ by FACS

    Measured: Baseline to up to 11 days after the 1st drug administration

  7. Changes in comparison with baseline level absolute reticulocyte count

    Measured: Baseline to up to 24 days after 1st the drug administration

  8. Change of concentration of G-CSF by ELISA

    Measured: Baseline to up to 11 days after the 1st drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02778763
Sponsor's protocol ID
BL-612-BC1
Status last verified
Jul 2016
First submitted
17 Mar 2016
Last updated
20 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBLB612 in people with Breast Cancer, run by BioLab 612 LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of ANC <1.0 x 103/μl (Grade 3-4) (time frame: Baseline to up to 38 days after the 1st drug administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02778763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.

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