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A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

NCT00629876 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2011-12-01

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of peginesatide used to treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer or prostate cancer and who also receiving a taxane chemotherapy.

Conditions

Interventions

DRUG

Peginesatide

Peginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles. Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen.

Sponsors & Collaborators

  • Affymax

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Vice President Clinical Science · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00629876 on ClinicalTrials.gov