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Sponsored by: |
ImmunoGen, Inc. |
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Information provided by: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT00065429 |
The study is currently in the Phase II efficacy expansion stage. The trial primarily focuses on efficacy of BB-10901 in relapsed small cell lung cancer, and continues to assess the safety, tolerability, and PK of BB-10901, administered weekly for 4 weeks.
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Drug: BB-10901 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion |
Enrollment: | 32 |
Study Start Date: | April 2003 |
Study Completion Date: | December 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
The Phase II efficacy expansion will be restricted to SCLC patients with relapsed disease and will treat patients at the MTD as determined by the Phase I portion of the trial (60mg/m2).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
United States, Colorado | |
Rocky Mountain Cancer Centers | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Cancer Center of Florida | |
Ocoee, Florida, United States, 34761 | |
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01107 | |
United States, New York | |
New York Oncology Hematology | |
Albany, New York, United States, 12208 | |
United States, Ohio | |
The Ohio State University | |
Colombus, Ohio, United States, 43221 | |
Greater Dayton Cancer Center | |
Kettering, Ohio, United States, 45409 | |
United States, South Carolina | |
Cancer Centers of the Carolinas | |
Greenville, South Carolina, United States, 29605 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-7095 | |
Tyler Cancer Center | |
Tyler, Texas, United States, 75702 | |
United States, Virginia | |
Virginia Oncology Associates | |
Norfolk, Virginia, United States, 23502 | |
United States, Washington | |
Northwest Cancer Specialists | |
Vancouver, Washington, United States, 98684 |
Responsible Party: | ImmunoGen, Inc. ( VP of Clinical Operations ) |
Study ID Numbers: | C10/IVB/001 |
Study First Received: | July 23, 2003 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00065429 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue |