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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01006785
• Other study ID #: DLBS1425-0209
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 2009
• Last updated: October 17, 2012
• Start date: August 2009
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical 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 cancer

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• DLBS1425
3 X 150 mg daily for 12 - 16 weeks of treatment
• DLBS1425
3 X 300 mg daily for 12 - 16 weeks of treatment

Locations

Country	Name	City	State
Indonesia	Dr. Hasan Sadikin Hospital, Department of Internal Medicine	Bandung	West Java
Indonesia	Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology	Jakarta	DKI Jakarta
Indonesia	Dr. Sardjito Hospital, Department of Internal Medicine	Yogyakarta	DI Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 -16 weeks	No
Secondary	Time point overall response rate		6 weeks	No
Secondary	Routine hematology	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	Yes
Secondary	Liver function	Liver function including alkaline phosphatase, serum ALT, serum AST, and bilirubin	at interval of 2 weeks over the 12 -16 weeks of treatment	Yes
Secondary	Renal function	Renal function including serum creatinine	at interval of 2 weeks over the 12 -16 weeks of treatment	Yes
Secondary	ECHO		at baseline and at week 6, 12, and 16 of treatment	Yes
Secondary	Adverse events		during 12 - 16 weeks of treatment	Yes