A Study of the Safety and Effectiveness of Trabetedin Versus Doxorubicin-based Chemotherapy in Patients With Translocation-Related Sarcomas (TRS)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to evaluate the effectiveness of trabetedin compared to standard doxorubicin-based chemotherapy as first-line treatment in patients with advanced Translocation-Related Sarcomas (a type of cancer). |
|---|---|
| Condition | Translocation, Genetic Sarcoma, Soft Tissue |
| Intervention | Drug: Trabectedin Drug: Doxorubicin |
| Phase | Phase 3 |
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Responsible Party | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier | NCT00796120 |
| First Received | November 20, 2008 |
| Last Updated | April 18, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 20, 2008 |
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| Last Updated Date | April 18, 2013 |
| Start Date | November 2008 |
| Estimated Primary Completion Date | July 2011 |
| Current Primary Outcome Measures | Progression - Free Survival [Time Frame: Up to approximately 20 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of the Safety and Effectiveness of Trabetedin Versus Doxorubicin-based Chemotherapy in Patients With Translocation-Related Sarcomas (TRS) |
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| Official Title | A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS) |
| Brief Summary | The purpose of this study is to evaluate the effectiveness of trabetedin compared to standard doxorubicin-based chemotherapy as first-line treatment in patients with advanced Translocation-Related Sarcomas (a type of cancer). |
| Detailed Description | This is a randomized (patients will be assigned to treatment by chance), multicenter, Phase III trial to evaluate the effectiveness of trabectedin versus standard doxorubicin-based chemotherapy (DXCT) as first-line treatment of patients with advanced Translocation-Related Sarcomas (TRS) (a type of cancer), by comparing progression-free survival (PFS) in the two treatment arms (Treatment Arm A: Trabectedin; Treatment Arm B: Doxorubicin as a single agent or in combination with ifosfamide). Trabectedin 1.5 mg/m2 given intravenously (i.v.) over 24-hours; or doxorubicin 75 mg/m2 i.v. every 3 weeks, or doxorubicin 60 mg/m2 i.v.followed by ifosfamide in the range of 6 to 9 g/m2 every 3 weeks with proper hydration and ifosfamide chemoprotectant drugs. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Trabectedin 1.5 mg/m2 administered as a 24-hour i.v. infusion every three weeks Drug: Doxorubicin 75 mg/m2 i.v. every three weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 80 |
| Estimated Completion Date | July 2011 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Pathological diagnosis of TRS (institutional assessment) - Patients must have unresectable locally advanced or metastatic disease prior to enrollment - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2 - Adequate cardiac function. Exclusion Criteria: - Known hypersensitivity to any components of the i.v. formulation of trabectedin or the comparator - Prior chemotherapy treatment of irradiation of the lesion - Brain metastases and/or leptomeningeal metastases, even if treated - Pregnant or lactating women - History of another neoplastic disease unless in remission for five years or more. Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, France, Germany, Spain, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00796120 |
|---|---|
| Other Study ID Numbers | CR015769 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Study Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Collaborators | PharmaMar |
| Investigators | Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| United States, California | Santa Monica, California, United States |
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| United States, Massachusetts | Boston, Massachusetts, United States |
| United States, New Mexico | Albuquerque, New Mexico, United States |
| United States, Pennsylvania | Philadelphia, Pennsylvania, United States |
| United States, Texas | Houston, Texas, United States |
| France | Boreaux, France |
| France | Lille, France |
| France | Lyon, France |
| France | Paris, France |
| France | Villejuif, France |
| Germany | Bad Saarow, Germany |
| Germany | Köln, Germany |
| Germany | Mannheim, Germany |
| Spain | Barcelona, Spain |
| Spain | Palma De Mallorca N/A, Spain |
| Spain | Valencia N/A, Spain |
| United Kingdom | Edinburgh, United Kingdom |
| United Kingdom | Glasgow, United Kingdom |
| United Kingdom | London, United Kingdom |
| United Kingdom | Manchester, United Kingdom |