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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00113607 |
The purpose of this research study is to determine if the combination of Yondelis and Doxil is better at improving overall survival over Doxil alone in subjects with relapsed advanced ovarian cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: Yondelis Drug: DOXIL |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of Doxil/Caelyx and Yondelis to Doxil/Caelyx Alone in Subjects With Advanced Relapsed Ovarian Cancer |
Estimated Enrollment: | 650 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
DOXIL, 30mg/m2 follwed by YONDELIS, 1.1 mg/m2 every q3wk
|
Drug: Yondelis
1.1 mg/m2 q3wk
Drug: DOXIL
30mg/m2 followed by YONDELIS, 1.1 mg/m2 q3wk
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2: Experimental
DOXIL, 50 mg/m2 q4wk
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Drug: DOXIL
DOXIL 50mg/m2 q4wk
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Investigator: | Johnson & Johnson Pharmaceutical Research & Development, LLC |
Responsible Party: | Johnson and Johnson Pharmaceutical Research and Development ( Eliel Bayever, Sr. Director Clinical Research ) |
Study ID Numbers: | ET743-OVA-301, ET743-OVA-301 |
Study First Received: | June 9, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00113607 |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer Advanced Relapsed Ovarian Cancer |
Ecteinascidin 743 Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Doxorubicin Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Antineoplastic Agents, Alkylating Antibiotics, Antineoplastic Alkylating Agents Pharmacologic Actions Adnexal Diseases |