Breast CancerPhase 2NCT01006785
Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer
A Phase 2 study testing DLBS1425 in people with Breast Cancer, run by Dexa Medica Group at 3 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DLBS1425
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesIndonesia
- Study dates
- Aug 2009to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Dr. Hasan Sadikin Hospital, Department of Internal Medicine
Bandung, West Java, 40161
Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
Jakarta, DKI Jakarta
Dr. Sardjito Hospital, Department of Internal Medicine
Yogyakarta, DI Yogyakarta, 55284
About this study
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
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
- Conditions
- Breast Cancer
- Being tested
- DLBS1425
- Keywords
- Breast Cancer, DLBS 1425, Cancer, Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS1425Drug
3 X 150 mg daily for 12 - 16 weeks of treatment
DLBS1425Drug
3 X 300 mg daily for 12 - 16 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment I | Experimental | DLBS1425 150 mg three times daily Receives: Drug: DLBS1425 |
| Treatment II | Experimental | DLBS1425 300 mg three times daily Receives: Drug: DLBS1425 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 -16 weeks
Secondary outcomes (6)
Time point overall response rate
Measured: 6 weeks
Routine hematology
Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count
Measured: at interval of 2 weeks over the 12 -16 weeks of treatment
Liver function
Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin
Measured: at interval of 2 weeks over the 12 -16 weeks of treatment
Renal function
Renal function including serum creatinine
Measured: at interval of 2 weeks over the 12 -16 weeks of treatment
ECHO
Measured: at baseline and at week 6, 12, and 16 of treatment
Adverse events
Measured: during 12 - 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: The study was terminated due to difficulty of find eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdul Muthalib, Prof. Dr., Principal investigator, Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006785
- Sponsor's protocol ID
- DLBS1425-0209
- Status last verified
- Oct 2012
- First submitted
- 1 Nov 2009
- Last updated
- 18 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01006785
- Acronym / sponsor ID
- DLBS1425-0209
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, DLBS 1425, Cancer, Advanced/Metastatic (Stage IIIB/IV) Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to difficulty of find eligible subjects
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment I | Experimental | Drug: DLBS1425DLBS1425 150 mg three times daily |
| Treatment II | Experimental | Drug: DLBS1425DLBS1425 300 mg three times daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS14253 X 150 mg daily for 12 - 16 weeks of treatment | Drug | Treatment I |
| DLBS14253 X 300 mg daily for 12 - 16 weeks of treatment | Drug | Treatment II |
Primary outcome
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
6 secondary outcomes
Time point overall response rate
Time frame: 6 weeks
Routine hematology
Time frame: at interval of 2 weeks over the 12 -16 weeks of treatment
Liver function
Time frame: at interval of 2 weeks over the 12 -16 weeks of treatment
Renal function
Time frame: at interval of 2 weeks over the 12 -16 weeks of treatment
ECHO
Time frame: at baseline and at week 6, 12, and 16 of treatment
Adverse events
Time frame: during 12 - 16 weeks of treatment
Results and safety
The study was stopped early (reason given: The study was terminated due to difficulty of find eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Muthalib, Prof. Dr. principal investigator
Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DLBS1425 in people with Breast Cancer, run by Dexa Medica Group at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to difficulty of find eligible subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.