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

This study has been terminated.
(The study was terminated due to difficulty of find eligible subjects)
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01006785
First received: November 1, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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

Condition Intervention Phase
Breast Cancer
Drug: DLBS1425
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

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 [ Time Frame: 12 -16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time point overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Routine hematology [ Time Frame: at interval of 2 weeks over the 12 -16 weeks of treatment ] [ Designated as safety issue: Yes ]
    Routine hematology including hemoglobin, hematocrit, red blood cells, white blood cells, differentiation of WBC, and platelet count

  • Liver function [ Time Frame: at interval of 2 weeks over the 12 -16 weeks of treatment ] [ Designated as safety issue: Yes ]
    Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin

  • Renal function [ Time Frame: at interval of 2 weeks over the 12 -16 weeks of treatment ] [ Designated as safety issue: Yes ]
    Renal function including serum creatinine

  • ECHO [ Time Frame: at baseline and at week 6, 12, and 16 of treatment ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: during 12 - 16 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: August 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment I
DLBS1425 150 mg three times daily
Drug: DLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
Experimental: Treatment II
DLBS1425 300 mg three times daily
Drug: DLBS1425
3 X 300 mg daily for 12 - 16 weeks of treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006785

Locations
Indonesia
Dr. Sardjito Hospital, Department of Internal Medicine
Yogyakarta, DI Yogyakarta, Indonesia, 55284
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, 40161
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01006785     History of Changes
Other Study ID Numbers: DLBS1425-0209
Study First Received: November 1, 2009
Last Updated: October 17, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
Breast Cancer
DLBS 1425
Cancer
Advanced/Metastatic (Stage IIIB/IV) Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014