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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00467012 |
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: bevacizumab Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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step 1: Experimental
6 enrollment for 1 cycle(4 weeks)
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Drug: bevacizumab
10mg/kg,Day1, 15 of 1 cycle(4 weeks)
Drug: Paclitaxel
90mg/ m2,Day1, 8, 15 of 1 cycle(4 weeks)
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step 2: Experimental
114 enrollment through to meet the stopping criteria
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Drug: bevacizumab
10mg/kg,Day1, 15 of 1 cycle(4 weeks)
Drug: Paclitaxel
90mg/ m2,Day1, 8, 15 of 1 cycle(4 weeks)
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Japan | |
Tohoku region | |
Tohoku, Japan | |
Kanto Region | |
Kanto, Japan | |
Kinki Region | |
Kinki, Japan | |
Kyushu region | |
Kyushu, Japan | |
Sikoku region | |
Sikoku, Japan |
Study Chair: | Shingo Koganezawa | Clinical research department 3 |
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | JO19901 |
Study First Received: | April 26, 2007 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00467012 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Inoperable metastatic breast cancer |
Skin Diseases Paclitaxel Tubulin Modulators Breast Neoplasms Antimitotic Agents |
Bevacizumab Angiogenesis Inhibitors Antineoplastic Agents, Phytogenic Breast Diseases |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Breast Neoplasms Bevacizumab Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Breast Diseases |