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Sponsors and Collaborators: |
Accelerated Community Oncology Research Network ONYX Pharmaceuticals |
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Information provided by: | Accelerated Community Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT00493636 |
The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine versus patients treated with placebo and gemcitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a bevacizumab-containing regimen.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Gemcitabine Drug: Sorafenib Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Placebo Control, Randomized, Safety/Efficacy Study, Treatment |
Official Title: | A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo When Administered in Combination With Chemotherapy for Patients With Locally Advanced or MBC That Has Progressed During or After Bevacizumab Therapy |
Estimated Enrollment: | 220 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
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Drug: Gemcitabine
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Drug: Sorafenib
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Drug: Gemcitabine
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
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B: Placebo Comparator
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours)
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Drug: Placebo
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lindsey Scrip | 901.259.8286 | lscrip@acorncro.com |
Study Chair: | Lee S Schwartzberg, MD, FACP | Accelerated Community Oncology Research Network Inc |
Study Chair: | Clifford A Hudis, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Accelerated Community Oncology Research Network ( Amanda Epperson, Sr. Project Manager ) |
Study ID Numbers: | ACORN AC01B07 |
Study First Received: | June 26, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00493636 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer |
Antimetabolites Radiation-Sensitizing Agents Skin Diseases Breast Neoplasms Bevacizumab Gemcitabine |
Protein Kinase Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents Antiviral Agents Sorafenib Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Protein Kinase Inhibitors Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |
Gemcitabine Breast Diseases Skin Diseases Growth Substances Breast Neoplasms Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Sorafenib |