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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: Completed Phase 1 study, sponsored by Genzyme, a Sanofi Company.

NCT00125840 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Start Date 2002-08
Est. Completion 2007-08
Phase Phase 1
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00125840 record still lists

NCT00125840 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 0 conditions, and to 1 intervention - of which clofarabine (IV formulation) is the first listed.

NCT00125840 does not publish any study locations in the registry export this page uses.

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.

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Source: ClinicalTrials.gov NCT00125840, the US trial registry maintained by the National Library of Medicine. NCT00125840 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.