NCT04298333

Brief Summary

The purpose of this study is to estimate the cumulative Maximum Tolerated Dose (MTD) and Minimum Efficient Dose (MED) of BP-C1 in the short-term treatment of metastatic breast cancer patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2011

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

February 25, 2020

Last Update Submit

March 4, 2020

Conditions

Metastatic Breast CancerStage IV Breast Cancer

Keywords

BP-C1Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from ligninBenzene polycarboxylic acids complex with cis-diammineplatinum(II)Metastatic Breast CancerPlatinum analogueMetronomic chemotherapyBreast cancerCisplatinCis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin

Outcome Measures

Primary Outcomes (2)

  • Change in Maximum Common Terminology Criteria (CTC) score for Adverse Events

    Maximum CTC score will be recorded using CTC v2.0 given as the highest observed CTC score at a given visit. The CTC scores will be recorded using CTC v2.0 divided in 15 System Organ Classes

    baseline to Day 32 of treatment and Day 28 of follow-up

  • Sum Common Terminology Criteria (CTC) score for Adverse Events

    The Sum CTC score will be a sum of all registered CTC scores obtained at a given visit. The CTC scores will be recorded using CTC v2.0 divided in 15 System Organ Classes

    baseline to Day 32 of treatment and Day 28 of follow-up

Secondary Outcomes (3)

  • Number of registered Adverse Events (AEs)

    baseline to Day 32 of treatment period and Day 28 of follow-up

  • Treatment Response

    baseline to Day 32 of treatment and Day 28 of follow-up

  • Proportion of patients with Disease Control Rate (DCR)

    baseline to Day 32 of treatment and Day 28 of follow-up

Study Arms (1)

BP-C1

EXPERIMENTAL

BP-C1 will be used as supportive care

Drug: BP-C1

Interventions

BP-C1DRUG

BP-C1, 0.05% solution for injection, will be administered intramuscularly once per day. The cumulative dose range will be 0.64-1.12 mg/kg body weight depending on design level (design level 1-3). The daily dose range will be 0.02-0.035 mg/kg body weight (0.04-0.07 mL/kg) depending on design level (design level 1-3). Dose level 1: 0.02 mg/kg body weight (0.04 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 2: 0.03 mg/kg body weight (0.06 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 3: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days. Changes in the cumulative dose of BP-C1 between patients in the sequence are predefined and will be adjusted by escalation/deescalation rules based on changes in toxicity observed in the previous design level. The duration of BP-C1 treatment will be 32 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

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
  • 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 haematology status defined by haemoglobin \< 9.0 g/dL, platelet count \< 100,000/mm\^3 or leucocytes \< 3x10\^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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanglah University Hospital

Bali, Indonesia

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: The study will be open-label, multi-center with a sequential safety design based on 3-level between-patient Response Surface Pathway (RSP) algorithm. Three patients will be recruited consecutively to each sequence of three dose levels (dose level 1 - cumulative dose 0.64 mg/kg body weight, dose level 2 - cumulative dose 0.96 mg/kg body weight, dose level 3 - cumulative dose 1.12 mg/kg body weight).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 6, 2020

Study Start

June 27, 2009

Primary Completion

January 4, 2011

Study Completion

January 4, 2011

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)ID(1)TH(1)