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| Sponsored by: |
ImmunoGen, Inc. |
| Information provided by: | ImmunoGen, Inc. |
| ClinicalTrials.gov Identifier: | NCT00065429 |
Purpose
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 |
|
Small Cell Lung Cancer |
Drug: BB-10901 |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| 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 |
| Estimated Enrollment: | 35 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | February 2009 (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).
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| United States, Colorado | |||||
| Rocky Mountain Cancer Centers | Recruiting | ||||
| Denver, Colorado, United States, 80218 | |||||
| Contact: Joni Newan 303-285-5011 joni.newman@usoncology.com | |||||
| Principal Investigator: Michele Basche, MD | |||||
| United States, Florida | |||||
| Cancer Center of Florida | Recruiting | ||||
| Ocoee, Florida, United States, 34761 | |||||
| Contact: Jocelyn Budzynski 407-292-3042 Jocelyn.Budzynski@usoncology.com | |||||
| Principal Investigator: Barry Berman, MD | |||||
| United States, Massachusetts | |||||
| Baystate Medical Center | Recruiting | ||||
| Springfield, Massachusetts, United States, 01107 | |||||
| Contact: Cheryl Carr 413-794-0255 cheryl.carr@chs.org | |||||
| Principal Investigator: John McCann, MD | |||||
| United States, New York | |||||
| New York Oncology Hematology | Recruiting | ||||
| Albany, New York, United States, 12208 | |||||
| Contact: Michele Butler 518-489-2607 michele.butler@usoncology.com | |||||
| Contact: Joanna Walsh 518 262 6696 joanna.walsh@usoncology.com | |||||
| Principal Investigator: Lawrence Garbo, MD | |||||
| Sub-Investigator: Francis Nugent, MD | |||||
| United States, Ohio | |||||
| The Ohio State University | Recruiting | ||||
| Colombus, Ohio, United States, 43221 | |||||
| Contact: Barbara McCracken 614-293-4254 bussa-1@medctr.osu.edu | |||||
| Principal Investigator: Miguel Villalona, MD | |||||
| Greater Dayton Cancer Center | Recruiting | ||||
| Kettering, Ohio, United States, 45409 | |||||
| Contact: Michelle Owens 937-528-0317 michelle.owens@usoncology.com | |||||
| Contact: Milissa Smith same milissa.smith@usoncology.com | |||||
| Principal Investigator: Robert Raju, MD | |||||
| United States, South Carolina | |||||
| Cancer Centers of the Carolinas | Recruiting | ||||
| Greenville, South Carolina, United States, 29605 | |||||
| Contact: Julie Martin 864-679-3966 julie.martin@usoncology.com | |||||
| Principal Investigator: Joseph Stephenson, MD | |||||
| United States, Texas | |||||
| MD Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77030-7095 | |||||
| Contact: Hannah Brewer 713-745-6767 hmbrewer@mdanderson.org | |||||
| Principal Investigator: Frank Fossella, MD | |||||
| Tyler Cancer Center | Recruiting | ||||
| Tyler, Texas, United States, 75702 | |||||
| Contact: Linda Dunkling 903-579-9800 linda.dunkling@usoncology.com | |||||
| Principal Investigator: Donald Richards, MD | |||||
| United States, Virginia | |||||
| Virginia Oncology Associates | Recruiting | ||||
| Norfolk, Virginia, United States, 23502 | |||||
| Contact: Wendi Gobhardt 757-466-8683 wendi.gobhardt@usoncology.com | |||||
| Principal Investigator: Paul Conkling, MD | |||||
| United States, Washington | |||||
| Northwest Cancer Specialists | Recruiting | ||||
| Vancouver, Washington, United States, 98684 | |||||
| Contact: Judith Welch 360-449-6522 judith.welch@usoncology.com | |||||
| Principal Investigator: David Smith, MD | |||||
| ImmunoGen, Inc. |
More Information
| Responsible Party: | ImmunoGen, Inc. ( VP of Clinical Operations ) |
| Study ID Numbers: | C10/IVB/001 |
| First Received: | July 23, 2003 |
| Last Updated: | April 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00065429 |
| Health Authority: | United States: Food and Drug Administration |
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