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

Neoplasms Clinical Trial

Official title:

A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050427
• Other study ID #: CR004525
• Secondary ID: ET743-INT-3
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2002
• Last updated: April 26, 2011
• Start date: December 2002
• Est. completion date: December 2006

Study information

• Verified date: April 2011
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Other known NCT identifiers

• NCT01328327

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms
• Neoplasms
• Neoplasms by Site
• Skin Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	PharmaMar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with objective response in each treatment arm.		Up to approximately 52 weeks	No
Secondary	Progression-free survival (PFS)		Up to approximately 52 weeks	No
Secondary	Time to progression (TTP)		Up to approximately 52 weeks	No
Secondary	Overall survival (OS)		Up to approximately 52 weeks	No
Secondary	The number of patients with treatment-emergent adverse events		Up to approximately 52 weeks	No
Secondary	Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin		During the first two 28-day treatment cycles	No