NCT01006785

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

2.6 years

First QC Date

November 1, 2009

Last Update Submit

October 17, 2012

Conditions

Breast Cancer

Keywords

Breast CancerDLBS 1425CancerAdvanced/Metastatic (Stage IIIB/IV) Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Time point overall response rate

    6 weeks

  • Routine hematology

    at interval of 2 weeks over the 12 -16 weeks of treatment

  • Liver function

    at interval of 2 weeks over the 12 -16 weeks of treatment

  • Renal function

    at interval of 2 weeks over the 12 -16 weeks of treatment

  • ECHO

    at baseline and at week 6, 12, and 16 of treatment

  • +1 more secondary outcomes

Study Arms (2)

Treatment I

EXPERIMENTAL

DLBS1425 150 mg three times daily

Drug: DLBS1425

Treatment II

EXPERIMENTAL

DLBS1425 300 mg three times daily

Drug: DLBS1425

Interventions

DLBS1425DRUG

3 X 150 mg daily for 12 - 16 weeks of treatment

Treatment I

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dr. Sardjito Hospital, Department of Internal Medicine

Yogyakarta, DI Yogyakarta, 55284, Indonesia

Location

Dr. Cipto Mangunkusumo Hospital, Division of Medical Haematology and Oncology

Jakarta, DKI Jakarta, Indonesia

Location

Dr. Hasan Sadikin Hospital, Department of Internal Medicine

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsNeoplasm Metastasis

Interventions

DLBS 1425

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdul Muthalib, Prof. Dr.

    Division of Medical Haematology and Oncology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2009

First Posted

November 3, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

ID(3)