Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer

October 17, 2012 updated by: Dexa Medica Group

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DI Yogyakarta
      • Yogyakarta, DI Yogyakarta, Indonesia, 55284
        • Dr. Sardjito Hospital, Department of Internal Medicine
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Dr. Hasan Sadikin Hospital, Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment I
DLBS1425 150 mg three times daily
Drug: DLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
Drug: DLBS1425
3 X 300 mg daily for 12 - 16 weeks of treatment
EXPERIMENTAL: Treatment II
DLBS1425 300 mg three times daily
Drug: DLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
Drug: DLBS1425
3 X 300 mg daily for 12 - 16 weeks of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 -16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time point overall response rate
Time Frame: 6 weeks
6 weeks
Routine hematology
Time Frame: at interval of 2 weeks over the 12 -16 weeks of treatment
Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count
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
Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin
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
Renal function including serum creatinine
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
at baseline and at week 6, 12, and 16 of treatment
Adverse events
Time Frame: during 12 - 16 weeks of treatment
during 12 - 16 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dexa Medica Group

Investigators

  • Principal Investigator: Abdul Muthalib, Prof. Dr., Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

November 1, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (ESTIMATE)

November 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLBS1425-0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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