Solid Tumors Clinical Trial
Official title:
A Phase I Dose Escalation and Pharmacokinetic Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory 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 is a research study of clofarabine that will be given to patients (orally) with
advanced cancerous tumors or cancerous tumors that have spread in which standard 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 oral clofarabine that can be safely given daily for 5 days
followed by 23 days of rest and repeated every 28 days?
2. What are the side effects of clofarabine when given on this schedule?
3. How much oral clofarabine is in the blood at specific times after administration and
how does the body get rid of the drug?
4. Will oral clofarabine help treat solid tumor cancer?
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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