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

NCT03603197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-10-07

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Meddoc

    collaborator OTHER

  • Norwegian University of Life Sciences

    collaborator OTHER

  • Meabco A/S

    lead INDUSTRY

Principal Investigators

  • Kritiya Butthongkomvong, MD · Udon Thani Cancer Hospital, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-05
Primary Completion
2016-08-30
Completion
2016-08-30

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603197 on ClinicalTrials.gov