Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00125840 · ClinicalTrials.gov registry record · Phase 1
Clofarabine in Adult Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00125840 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company.
The verdict
NCT00125840, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
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?
Interventions
- DRUG clofarabine (IV formulation)
Trial Details
| Field | Value |
|---|---|
| Start Date | 2002-08 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125840
The ClinicalTrials.gov registry entry for NCT00125840 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which clofarabine (IV formulation) is the first listed.
NCT00125840 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00125840 about?
NCT00125840 is a clinical study titled "Clofarabine in Adult Patients With Advanced Solid Tumors". 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 can...
What is the current status of trial NCT00125840?
This trial is currently completed. It is a Phase 1 study. The study started on 2002-08. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00125840?
The interventions under investigation include: clofarabine (IV formulation) (DRUG).
Who is sponsoring clinical trial NCT00125840?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.