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Breast CancerPhase 2NCT02115984

Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer

A Phase 2 study testing Panagen and Chemotherapy in people with Breast Cancer, run by Panagen, Limited Liability Company.

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

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). 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?
Panagen and Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
No sites listed yet
Study dates
May 2010to May 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed and dated written informed consent
  • Women at an age of ≥18 years
  • Stage II-IV breast cancer (with distant metastases)
  • The patients will be subject to chemotherapy with cyclophosphan/doxorubicin/ fluorouracil as a standard chemotherapy for treating breast cancer
  • The patients have not been earlier subject to chemotherapy
  • Functional status according to the Eastern Cooperative Oncology Group (ECOG) ≤2
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  • Leukocyte counts of ≥3 × 109/L before the treatment course
  • Neutrophil counts of ≥1.5 × 109/L before the treatment course
  • Platelet counts of ≥100 × 109/L before the treatment course
  • Adequate heart function
  • Adequate liver function, that is, alanine aminotransferase / aspartate aminotransferase (ALT / AST) activity < 2.5 × upper limit of normal (ULN); acid phosphatase activity < 5 × ULN; and bilirubin concentration < 5 × ULN; and
  • Adequate renal function, that is, the creatinine concentration in the blood serum < 1.5 × ULN; urea concentration < ULN; and endogenous creatinine clearance

Who cannot join

  • Participation in clinical trials less than 30 days before sequential randomization
  • Previous exposure to Panagen or any other leukostimulatory drugs at a stage of clinical development
  • Known hypersensitivity to cyclophosphan, doxorubicin, or fluorouracil
  • Therapy with systemically active antibiotics less than 72 h before the beginning of chemotherapy
  • Long-term oral intake of corticosteroids
  • Previous X-ray therapy performed less than 4 weeks before randomization
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  • Previous transplantation of hematopoietic stem cells
  • Other malignant neoplasms during the last 5 years except for basal cell or flat cell carcinoma or intraepithelial carcinoma of the uterine cervix
  • Any disease or state that according to the opinion of researcher can influence patient's safety or the estimation of a final trial point; and
  • Pregnant and nursing women; the fertile patients should use chemical or barrier contraceptives during the period of trials

About this study

Official title: Double-blind Multicenter Placebo-controlled Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer

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).

Read the detailed description

The limited liability company Panagen has designed the preparation named Panagen in a form of tablets, which is represented by a fragmented nucleoprotein complex isolated from the human placenta. The method allows for extraction of a full-fledged genomic DNA with retention of its fragments that are tightly associated with the nuclear matrix proteins. The length of fragmented DNA varies from 200 to 6000 base pairs.

This trial is a double-blind multisite placebo-controlled sequentially randomized phase II trial involving two groups of patients. Totally, 80 stage II breast cancer cases with an increased risk or stage III-IV breast cancer cases (with distant metastases) requiring chemotherapy will participate in this trial. All patients will be sequentially randomized, that is, any patient independently of the time she is included into this study may fall into one of the two groups. The patients will be divided into two groups at a ratio of 3 : 1; the first group receiving the preparation Panagen will contain 60 persons and the second one, receiving placebo, 20 persons. For the reasons of ethics, the size of the second group minimally possible for obtaining statistically significant data is chosen. The patients will be subject to a standard chemotherapy, including 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil; all preparations are administered intravenously once a day. In this trial, the patients will receive three chemotherapy courses with an interval of 3 weeks between the courses (unless an interruption is required).

On the background of this chemotherapy, the patients will receive the preparation Panagen at a dose of 30 mg/day or a placebo with a fractional uniform administration during the active day period, which will amount to one tablet six times a day (every 2 h). The patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (day 3) and continue its administration for 17 days to and thorough day 20 after the chemotherapy. If the next chemotherapy course is delayed, the patients continue taking Panagen. The intake should be stopped 1 day before the next chemotherapy course. It is admissible to delay the next chemotherapy course by 1 week.

Conditions
Breast Cancer
Being tested
Panagen, Placebo, Chemotherapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PanagenDrug

    Also called sodium deoxyribonucleate, double-stranded human DNA

  • PlaceboDrug

  • ChemotherapyProcedure or surgery

    Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.

Study groups in NCT02115984
Study groupRoleWhat they receive
Chemotherapy & PanagenExperimentalPanagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
Receives: Drug: Panagen; Procedure: Chemotherapy
Chemotherapy & PlaceboPlacebo comparatorPlacebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy).
Receives: Drug: Placebo; Procedure: Chemotherapy

What is being measured

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

  1. The Quantity of Leukocytes and Neutrophils in the Blood of Patients

    Measured: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)

Timeline

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

  1. First posted16 Apr 2014 (estimated)
  2. Study startMay 2010
  3. Primary completionMay 2012
  4. Study completionMay 2012

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02115984
Sponsor's protocol ID
P-bc-2
Status last verified
Apr 2014
First submitted
7 Apr 2014
Last updated
15 Jul 2014
Data monitoring committee
No

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.

    PubMed 27538465

  • 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.

    PubMed 25886605

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panagen and Chemotherapy in people with Breast Cancer, run by Panagen, Limited Liability Company.

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 12 inclusion and 10 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 15 Jul 2014. 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?

Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Quantity of Leukocytes and Neutrophils in the Blood of Patients (time frame: Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)). 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 NCT02115984, which also lists 2 linked publications.

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 15 Jul 2014.

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