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

NCT02115984 | Completed Phase 2 Results

• 1 other identifier: P-bc-2
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The Quantity of Leukocytes and Neutrophils in the Blood of Patients

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

Study Arms (2)

Chemotherapy & Panagen

EXPERIMENTAL

Panagen 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).

Drug: Panagen; Procedure: Chemotherapy

Chemotherapy & Placebo

PLACEBO COMPARATOR

Placebo 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).

Drug: Placebo; Procedure: Chemotherapy

Interventions

Panagen DRUG

Also known as: sodium deoxyribonucleate, double-stranded human DNA

Chemotherapy & Panagen

Placebo DRUG

Chemotherapy & Placebo

Chemotherapy PROCEDURE

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

Chemotherapy & Panagen; Chemotherapy & Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Panagen, Limited Liability Company: lead

Related Publications (2)

• 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.

  PMID: 27538465 DERIVED

• 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.

  PMID: 25886605 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Sergey S. Bogachev
• Organization: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences

labmolbiol@mail.ru

+7-963-946-57-69

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 16, 2014
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 15, 2014
• Results First Posted: July 15, 2014

Record last verified: 2014-04