A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
18 Years
N/A
Female
Breast Neoplasms, Neoplasms, Neoplasms by Site, Breast Diseases, Skin Diseases
Trial Information
A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
Patients will be enrolled in the study after all study specific-entry criteria are met and
informed consent is obtained. Patients will be required to attend regular clinic visits to
receive study medication and have their status monitored. Patients will also be required to
have radiologic tumor assessments performed at multiple times throughout the study. A
detailed explanation can be provided by the study physician (Investigator) conducting this
study. Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300
mcg/m2 once every 21 days (Treatment B) will be given to patients as a 3-hour intravenous
(i.v). infusion via a central venous catheter which is a tube placed into a large vein that
is used to administer medications. All patients will be given dexamethasone 10 mg i.v. 30
minutes before each trabectedin infusion. Patients may receive multiple cycles of
trabectedin in the absence of disease progression.
Inclusion Criteria:
- Diagnosis of advanced breast cancer
- Prior therapy with anthracycline and taxane (2 types of chemotherapy drugs)
- At least one measureable tumor lesion
- Adequate bone marrow, hepatic and renal function
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
- Known hypersensitivity to any components of the i.v. formulation of ET-743 or
dexamethasone
- Pregnant or lactating women
- Known metastases (spread) of cancer to the central nervous system
- History of another neoplastic disease unless in remission for five years or more.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients with objective response in each treatment arm.
Outcome Time Frame:
Up to approximately 52 weeks
Safety Issue:
No
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Food and Drug Administration
Study ID:
CR004525
NCT ID:
NCT00050427
Start Date:
December 2002
Completion Date:
December 2006
Related Keywords:
- Breast Neoplasms
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Skin Diseases
- Trabectedin
- Yondelis
- ET743
- Advanced breast cancer
- Breast
- Cancer
- Antineoplastic Agents, Alkylating Agents
- Molecular Mechanisms of Pharmacological Action
- Breast Neoplasms
- Breast Diseases
- Neoplasms
- Neoplasms by Site
- Skin Diseases
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