Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer
NCT ID: NCT01006785
Last Updated: 2012-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2009-08-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and
* to determine the minimal effective and safe dose of DLBS1425 in the therapy of advanced/metastatic breast cancer
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment I
DLBS1425 150 mg three times daily
DLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
Treatment II
DLBS1425 300 mg three times daily
DLBS1425
3 X 300 mg daily for 12 - 16 weeks of treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
DLBS1425
3 X 300 mg daily for 12 - 16 weeks of treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with the expression of ER/PR negative; or positive ER/PR expression but have failed with or refuse to receive hormonal therapy
* Either + or - expression of HER-2/neu gene
* ECOG status = 0-2
* At least have 1 evaluable and measurable metastatic lesion as defined by RECIST criteria
* Adequate haematological, liver, and renal function
* At least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy
* At least 4 weeks has elapsed since surgical biopsy / major surgery
Exclusion Criteria
* Any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation
* Concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dexa Medica Group
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Abdul Muthalib, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dr. Sardjito Hospital, Department of Internal Medicine
Yogyakarta, DI Yogyakarta, Indonesia
Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
Jakarta, DKI Jakarta, Indonesia
Dr. Hasan Sadikin Hospital, Department of Internal Medicine
Bandung, West Java, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DLBS1425-0209
Identifier Type: -
Identifier Source: org_study_id