A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
- Determine the safety and tolerability of BB-10901
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.* Treatment repeats
every 21 days
NOTE: *Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive
infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the
independent Safety Review Board.
Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6
patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the
After completion of study treatment, patients are followed for short term and long term
follow up and survival.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments
these tests will be conducted at various timepoints during a patients participation in the trial
Paul C. Lorigan, MD
Christie Hospital NHS Foundation Trust
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|University of California San Francisco||San Francisco, California 941104206|
|Nevada Cancer Institute||Las Vegas, Nevada 89135|
|Oklahoma University||Tulsa, Oklahoma 74104|
|The Ohio State University Cancer Center and Research Institute||Columbus, Ohio|