Clinical Trials Directory

Trials / Completed

CompletedNCT00283439

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Amgen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAMG 531Planned Cohorts: 1. 100 mcg, 2. 300 mcg, 3. 700 mcg, 4. 1000 mcg; Optional Cohorts: 5. cohort expansion, 6. schedule change, 7. new dose

Timeline

Start date
2005-10-01
Primary completion
2008-05-01
Completion
2008-09-01
First posted
2006-01-30
Last updated
2011-06-20
Results posted
2010-09-13

Source: ClinicalTrials.gov record NCT00283439. Inclusion in this directory is not an endorsement.