A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion
The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and
the MTD was determined by the Phase I portion of the trial (60mg/m2).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.
every 6 weeks
Yes
United States: Food and Drug Administration
C10/IVB/001
NCT00065429
April 2003
December 2008
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Tyler Cancer Center | Tyler, Texas 75702 |
Northwest Cancer Specialists | Vancouver, Washington 98664 |
The Ohio State University | Columbus, Ohio 43210 |
New York Oncology Hematology | Albany, New York 12208 |
Cancer Center of Florida | Ocoee, Florida 34761 |
Greater Dayton Cancer Center | Kettering, Ohio 45409 |