Trials / Completed
CompletedNCT01161511
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Xencor, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | XmAb5574 | Intravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1. (Cycle 1 on Days 1, 4, 8, 15, 22; Cycle 2 on Days 1, 8, 15, 22) |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2010-07-13
- Last updated
- 2014-04-21
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01161511. Inclusion in this directory is not an endorsement.