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| 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: | NCT00050414 |
Purpose
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Drug: Trabectedin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer |
| Enrollment: | 37 |
| Study Start Date: | October 2002 |
| Study Completion Date: | September 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Trabectedin 0.58 mg/m2 3-hour i.v. infusion Days 1 8 and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.
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Drug: Trabectedin
0.58 mg/m2, 3-hour i.v. infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.
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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 at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on Days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). All patients will receive dexamethasone 10 mg i.v. 30 minutes prior to 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | Sr Dir Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00050414 History of Changes |
| Obsolete Identifiers: | NCT01336504 |
| Other Study ID Numbers: | CR004057, ET743-INT-11 |
| Study First Received: | December 9, 2002 |
| Last Updated: | April 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Ovarian cancer Ovary Cancer Trabectedin Yondelis |
ET743 Ecteinascidin 743 Antineoplastic Agents, Alkylating Alkylating Agents |
|
Adnexal Diseases Neoplasms Endocrine Gland Neoplasms Genital Diseases, Female Neoplasms by Site Ovarian Neoplasms Ovarian Diseases Endocrine System Diseases Genital Neoplasms, Female |
Urogenital Neoplasms Gonadal Disorders Trabectedin Antineoplastic Agents Antineoplastic Agents, Alkylating Therapeutic Uses Pharmacologic Actions Alkylating Agents Molecular Mechanisms of Pharmacological Action |