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Completed Phase 1Phase 2 Interventional Results available

AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

ClinicalTrials.gov ID: NCT00147225

Public ClinicalTrials.gov record NCT00147225. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1\. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy

Study identification

NCT ID
NCT00147225
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
55 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2005
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013
Last update posted
May 7, 2014

2005 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UT MD Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00147225, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2014 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00147225 live on ClinicalTrials.gov.

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