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A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
PharmaMar
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00050427
First received: December 9, 2002
Last updated: April 26, 2011
Last verified: April 2011

December 9, 2002
April 26, 2011
December 2002
Not Provided
Number of patients with objective response in each treatment arm. [ Time Frame: Up to approximately 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00050427 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 52 weeks ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: Up to approximately 52 weeks ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to approximately 52 weeks ] [ Designated as safety issue: No ]
  • The number of patients with treatment-emergent adverse events [ Time Frame: Up to approximately 52 weeks ] [ Designated as safety issue: No ]
  • Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin [ Time Frame: During the first two 28-day treatment cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Breast Diseases
  • Skin Diseases
  • Drug: ET743
    580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
  • Drug: ET743
    1,300 mcg/m2, 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
  • Experimental: 001
    ET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
    Intervention: Drug: ET743
  • Experimental: 002
    ET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
    Intervention: Drug: ET743
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
December 2006
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00050427
CR004525, ET743-INT-3
Not Provided
Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP