BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment

NCT03789019 | Completed Phase 2

• 1 other identifier: BMC2011-02
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to establish an optimal treatment duration and tolerable cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had previously undergone at least three lines of chemotherapy.

Conditions

Metastatic Breast Cancer; Stage IV Breast Cancer

Keywords

BP-C1; Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin; Benzene polycarboxylic acids complex with cis-diammineplatinum( II); Metastatic Breast Cancer; Platinum analogue; Metronomic chemotherapy; Breast cancer; Cisplatin; cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin

Outcome Measures

Primary Outcomes (2)

• Sum Common Toxicity Criteria score (Sum CTC score)

  Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Sum CTC score will be calculated by taking the sum of each variable across all categories.

  baseline to Day 64 of treatment period

• Maximum Common Toxicity Criteria score (Maximum CTC score)

  Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Maximum CTC score will be calculated by taking the maximum value among all variables across all categories.

  baseline to Day 64 of treatment period

Secondary Outcomes (6)

• Change (%) in the sum of diameters of target lesions

  baseline to Day 64 of treatment period

• Treatment response

  baseline to Day 64 of treatment period

• Karnofsky Performance Status score (KPS score)

  baseline to Day 64 of treatment period

• Changes in sub-scores of the three major scales of general quality of life questionnaire (EORTC QLQ-C30)

  baseline to Day 64 of treatment period

• Changes in sub-scores of the specific quality of life questionnaire (EORTC QLQ-BR23)

  baseline to Day 64 of treatment period

Study Arms (1)

BP-C1

EXPERIMENTAL

Dose-response part: patients who have completed the first 32-day treatment period with BP-C1 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of "moderate" toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 under the protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days. Follow-up study: the patients will be given BP-C1 as long as they obtain benefit from the treatment (i.e. until disease progression or increase in toxicity not above "moderate" grade).

Drug: BP-C1

Interventions

BP-C1 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

Also known as: 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

BP-C1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Severe or life-threatening increase in toxicity after preceding 32-day treatment with BP-C1.
• 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 \<0.70 or international normalised ratio (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 3 weeks 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.

Sponsors & Collaborators

• Meabco A/S: lead
• Meddoc: collaborator
• Norwegian University of Life Sciences: collaborator

Study Sites (7)

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

Moscow, Russia

Location

Leningrad Regional Oncological Centre

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Lampang Cancer Hospital

Lampang, 52000, Thailand

Location

Ubon Ratchanthani Cancer Hospital

Ubon Ratchathani, Thailand

Location

Udon Thani Cancer Hospital

Udon Thani, Thailand

Location

Related Publications (2)

• 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.

  PMID: 25473312 RESULT

• Lindkaer-Jensen S, Larsen S, Habib-Lindkaer-Jensen N, Fagertun HE. Positive effects on hematological and biochemical imbalances in patients with metastatic breast cancer stage IV, of BP-C1, a new anticancer substance. Drug Des Devel Ther. 2015 Mar 13;9:1481-90. doi: 10.2147/DDDT.S80451. eCollection 2015.

  PMID: 25792808 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Henning Arboe

  Meabco A/S

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: December 28, 2018
• Study Start: February 22, 2013
• Primary Completion: July 29, 2016
• Study Completion: July 29, 2016
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4); RU (3)