BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer

NCT ID: NCT02783794

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-24
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of this study is to determine whether BP-C1 is effective in the treatment of metastatic breast cancer patients who had previously received at least three lines of chemotherapy.

Detailed Description

BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients with metastatic breast cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin. The amphiphilic characteristics of the polymer have resulted in a product with clear and significantly altered and improved properties compared to other platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.

BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin), additionally offering the following advantages that ensure favourable outcome of treatment of metastatic breast cancer patients:

• injectable solution (intramuscular) does not cause injection site reactions;
• can be administered at home by a nurse or a patient;
• has an improved pharmacokinetic profile;
• demonstrates efficacy comparable to cisplatin and much higher than carboplatin (in-vitro; in-vivo data);
• exerts an additional immunomodulatory activity.

This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study. The eligible patients will be allocated (1:1) to either BP-C1 arm or Placebo arm and treated once daily for 32 days. The patients allocated to Placebo arm will cross over to BP-C1 treatment for 32 days when progression of the cancer will be documented and latest after 32-day treatment with Placebo. After 32-day treatment with BP-C1 the patients are invited to participate in the study BMC2011-02 to continue open-label BP-C1 treatment.

Conditions

Metastatic Breast Cancer; Stage IV Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BP-C1

Patients randomized to BP-C1 arm will be treated for 32 consecutive days. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.

Group Type: EXPERIMENTAL

BP-C1

Intervention Type: DRUG

BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days

Placebo

Patients randomized to Placebo arm will be treated for 32 consecutive days. Thereafter the patients will cross over to 32-day treatment with BP-C1. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days

Interventions

BP-C1

BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days

Intervention Type: DRUG

Placebo

Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days

Intervention Type: DRUG

Other Intervention Names

Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin; Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin

Eligibility Criteria

Inclusion Criteria

Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months.

Exclusion Criteria

Patients fulfilling at least one of the following criteria will be excluded from participation in the study:

• Abnormal liver function classified as total bilirubin >34 μmol/L or ALAT > 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN.
• Abnormal kidney function defined by serum creatinine >120 μmol/L.
• Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR >1.5.
• Verified metastases to the brain.
• Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
• Abnormal hematology status defined by hemoglobin < 9.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.
• Clinically significant abnormal ECG.
• Karnofsky performance status score <60%.
• Pregnant or breast feeding women.
• Women of fertile age who do not want to be tested for possible pregnancy.
• Fertile female who do not want to use safe protection against pregnancy, starting one month before the start of the study treatment and lasting at least six weeks after.
• Uncontrolled bacterial, viral, fungal or parasite infection.
• Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment.
• Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.
• Not able to understand information.
• Not willing or not able to give written consent to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Meddoc

OTHER

Sponsor Role: collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role: collaborator

Meabco A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steen Lindkær-Jensen, MD

Role: STUDY_DIRECTOR

Meabco A/S

Locations

Russian Oncological Research Centre n.a. N.N. Blokhin, Russian Academy of Medical Science (RAMS)

Moscow, , Russia

State Budgetary Institution of Nizhniy Novgorod Region "Oncology Dispensary of Nizhniy Novgorod" (Branch nr.1)

Nizhny Novgorod, , Russia

Leningrad Regional Oncological Centre

Saint Petersburg, , Russia

St. Petersburg State Budgetary Health Organization, City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Udon Thani Cancer Hospital

Udon Thani, , Thailand

Countries

Russia; Thailand

References

Larsen S, Butthongkomvong K, Manikhas A, Trishkina E, Poddubuskaya E, Matrosova M, Srimuninnimit V, Lindkaer-Jensen S. BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase. Breast Cancer (Dove Med Press). 2014 Nov 27;6:179-89. doi: 10.2147/BCTT.S71781. eCollection 2014.

Reference Type: RESULT

PMID: 25473312 (View on PubMed)

Erratum: BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase [Corrigendum]. Breast Cancer (Dove Med Press). 2015 Jun 29;7:163. doi: 10.2147/BCTT.S84920. eCollection 2015.

Reference Type: RESULT

PMID: 26170717 (View on PubMed)

Other Identifiers

BMC2011-1

Identifier Type: -

Identifier Source: org_study_id