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Completed Phase 1 Interventional

Clofarabine in Adult Patients With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT00125840

Public ClinicalTrials.gov record NCT00125840. 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 23, 2026, 5:49 PM EDT

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

Official title

A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors

Brief summary

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

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions: 1. What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days? 2. What are the side effects of clofarabine when given on this schedule? 3. How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle. 4. Will clofarabine help treat a specific cancer?

Study identification

NCT ID
NCT00125840
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
Not listed

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, 2002
Primary completion
Not listed
Completion
Jul 31, 2007
Last update posted
Feb 4, 2014

2002 – 2007

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Mary Crowley Medical Research Center Dallas Texas 75246
US Oncology Tyler Cancer Center Tyler Texas 75702

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 NCT00125840, 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 Feb 4, 2014 · Synced Sep 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00125840 live on ClinicalTrials.gov.

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