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

• ClinicalTrials.gov Identifier: NCT00050427
• Recruitment Status: Completed
• First Posted: December 18, 2002
• Last Update Posted: April 28, 2011
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases	Drug: ET743	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer
• Study Start Date: December 2002
• Actual Study Completion Date: December 2006

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. Number of patients with objective response in each treatment arm. [ Time Frame: Up to approximately 52 weeks ]

Secondary Outcome Measures :

1. Progression-free survival (PFS) [ Time Frame: Up to approximately 52 weeks ]
2. Time to progression (TTP) [ Time Frame: Up to approximately 52 weeks ]
3. Overall survival (OS) [ Time Frame: Up to approximately 52 weeks ]
4. The number of patients with treatment-emergent adverse events [ Time Frame: Up to approximately 52 weeks ]
5. Concentrations of trabectedin in plasma as a measure of the pharmacokinetics of trabectedin [ Time Frame: During the first two 28-day treatment cycles ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PharmaMar

Investigators

• Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldstein LJ, Gurtler J, Del Prete SA, Tjulandin S, Semiglazov VF, Bayever E, Michiels B. Trabectedin as a single-agent treatment of advanced breast cancer after anthracycline and taxane treatment: a multicenter, randomized, phase II study comparing 2 administration regimens. Clin Breast Cancer. 2014 Dec;14(6):396-404. doi: 10.1016/j.clbc.2014.06.006. Epub 2014 Aug 15.

• Responsible Party: Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
• ClinicalTrials.gov Identifier: NCT00050427
• Obsolete Identifiers: NCT01328327
• Other Study ID Numbers: CR004525; ET743-INT-3
• First Posted: December 18, 2002
• Last Update Posted: April 28, 2011
• Last Verified: April 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Trabectedin; Yondelis; ET743; Advanced breast cancer; Breast; Cancer; Antineoplastic Agents, Alkylating Agents; Molecular Mechanisms of Pharmacological Action

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms; Neoplasms by Site; Skin Diseases; Breast Diseases; Trabectedin; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents