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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00863850 on ClinicalTrials.gov