A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

NCT ID: NCT00117117

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-12-31

Brief Summary

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The purpose of this trial is to prospectively assess the relationship between changes in hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients receiving chemotherapy supported with Aranesp®.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aranesp

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with nonmyeloid malignancy(ies)
* Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy

Exclusion Criteria

* Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS)
* Unstable cardiac disease or anemia due to other causes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Gregory SA. Efficacy of Darbepoetin Alfa in the Treatment of Chemotherapy-Induced Anemia in Non-Hodgkin's Lymphoma. Support Cancer Ther. 2006 Jul 1;3(4):232-9. doi: 10.3816/SCT.2006.n.021.

Reference Type RESULT
PMID: 18632499 (View on PubMed)

Gabrilove JL, Perez EA, Tomita DK, Rossi G, Cleeland CS. Assessing symptom burden using the M. D. Anderson symptom inventory in patients with chemotherapy-induced anemia: results of a multicenter, open-label study (SURPASS) of patients treated with darbepoetin-alpha at a dose of 200 microg every 2 weeks. Cancer. 2007 Oct 1;110(7):1629-40. doi: 10.1002/cncr.22943.

Reference Type RESULT
PMID: 17694552 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20020132

Identifier Type: -

Identifier Source: org_study_id

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