NCT00125827

Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

A Phase I Dose Escalation and Pharmacokinetic Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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?

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	clofarabine (oral formulation)	Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-10-01
• Completion: 2006-02-01
• First posted: 2005-08-02
• Last updated: 2014-03-19

Locations

3 sites across 1 country: United States