Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy
NCT00863850 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2012-04-23
Summary
An Open-Label Study to Investigate the Pharmacokinetics of Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)
Conditions
- Malignancy
Interventions
- DRUG
-
Bendamustine 120 mg/m2 on Days 1 and 2 every 28 days (one cycle) for up to 6 cycles. Radiolabeled \[14C\] bendamustine will be given on day 1 of cycle 1 only.
Sponsors & Collaborators
-
Cephalon
lead INDUSTRY
Principal Investigators
-
Sponsor's Medical Expert - Sr. Director, Clinical Pharmacology · Cephalon
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-03-31
Countries
- Netherlands
Study Locations
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