Back to resultsEfficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
DLBS1425
DLBS1425
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, DLBS 1425, Cancer, Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects diagnosed with Stage IIIB or IV breast cancer who have failed with or refuse to receive standard chemotherapies
- 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:
- Allergic to the trial product
- 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
Sites / Locations
- Dr. Sardjito Hospital, Department of Internal Medicine
- Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
- Dr. Hasan Sadikin Hospital, Department of Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment I
Treatment II
Arm Description
DLBS1425 150 mg three times daily
DLBS1425 300 mg three times daily
Outcomes
Primary Outcome Measures
Best overall response rate: proportion of subjects with either complete or partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria at the end of study
Secondary Outcome Measures
Time point overall response rate
Routine hematology
Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count
Liver function
Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin
Renal function
Renal function including serum creatinine
ECHO
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01006785
Brief Title
Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer
Official Title
Phase II Clinical Study: A Randomized, Open, and Dose Ranging Study to Evaluate the Efficacy and Safety of DLBS1425 in Subjects With Metastatic / Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to difficulty of find eligible subjects
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group
4. Oversight
5. Study Description
Brief Summary
The purposes of this study are :
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, DLBS 1425, Cancer, Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment I
Arm Type
Experimental
Arm Description
DLBS1425 150 mg three times daily
Arm Title
Treatment II
Arm Type
Experimental
Arm Description
DLBS1425 300 mg three times daily
Intervention Type
Drug
Intervention Name(s)
DLBS1425
Intervention Description
3 X 150 mg daily for 12 - 16 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
DLBS1425
Intervention Description
3 X 300 mg daily for 12 - 16 weeks of treatment
Primary Outcome Measure Information:
Title
Best overall response rate: proportion of subjects with either complete or partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria at the end of study
Time Frame
12 -16 weeks
Secondary Outcome Measure Information:
Title
Time point overall response rate
Time Frame
6 weeks
Title
Routine hematology
Description
Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count
Time Frame
at interval of 2 weeks over the 12 -16 weeks of treatment
Title
Liver function
Description
Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin
Time Frame
at interval of 2 weeks over the 12 -16 weeks of treatment
Title
Renal function
Description
Renal function including serum creatinine
Time Frame
at interval of 2 weeks over the 12 -16 weeks of treatment
Title
ECHO
Time Frame
at baseline and at week 6, 12, and 16 of treatment
Title
Adverse events
Time Frame
during 12 - 16 weeks of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects diagnosed with Stage IIIB or IV breast cancer who have failed with or refuse to receive standard chemotherapies
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:
Allergic to the trial product
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Muthalib, Prof. Dr.
Organizational Affiliation
Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sardjito Hospital, Department of Internal Medicine
City
Yogyakarta
State/Province
DI Yogyakarta
ZIP/Postal Code
55284
Country
Indonesia
Facility Name
Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
Dr. Hasan Sadikin Hospital, Department of Internal Medicine
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia
12. IPD Sharing Statement
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Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer
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