Ovarian Cancer Clinical Trial
Official title:
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in
treating patients with relapsed or refractory solid tumors.
OBJECTIVES:
Primary
- Determine the safety and tolerability of BB-10901
- Determine the maximum tolerated dose of this drug in these patients.
Secondary
- 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
MTD.
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
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