|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 |
| 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).
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 | |
| 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 | |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Carcinoma, Neuroendocrine Neoplasms, Nerve Tissue Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Glandular and Epithelial |