A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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Purpose
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
Drug: ET743 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- Number of patients with objective response in each treatment arm. [ Time Frame: Up to approximately 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 53 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050427
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
No publications provided
| Responsible Party: | Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00050427 History of Changes |
| Obsolete Identifiers: | NCT01328327 |
| Other Study ID Numbers: | CR004525, ET743-INT-3 |
| Study First Received: | December 9, 2002 |
| Last Updated: | April 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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 Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Trabectedin Antineoplastic Agents Dexamethasone Antineoplastic Agents, Alkylating Molecular Mechanisms of Pharmacological Action Therapeutic Uses Pharmacologic Actions |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Alkylating Agents |
ClinicalTrials.gov processed this record on May 22, 2013