NCT01003678

Safety and Tolerability of Oral Clofarabine in Intermediate to High Risk Myelodysplastic Patients

A Phase I Study Evaluating the Safety and Tolerability of Oral Clofarabine in Intermediate to High Risk Myelodysplastic Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I trial for patients with intermediate or high risk myelodysplastic syndrome (MDS). The study agent, clofarabine, is produced by Genzyme Pharmaceuticals.

Detailed description

The specific purpose of the study is to determine the safety, maximum tolerated dose (MTD) and recommended Phase II dose of clofarabine in patients with MDS. * We will start at a dose of 1 mg daily. * We will treat a group of 3 patients with clofarabine at that dose level. * If there are no severe side effects seen at that dose level, then the next group of 3 patients will receive a higher dose. * Treatment of groups of 3 patients will continue at higher dose levels until severe side-effects are noted. * If more than 1 of the 3 patients experiences a severe side effect, dosing will be stopped at that level. * If only one of the three patients experience a severe side effect, then three more patients will be treated, at that dose level and if they too experience severe side effects, then dose escalation will be stopped and the maximum tolerated dose will be determined. * 10 more patients will be enrolled at the maximum tolerated dose. * There will be up to 5 dose levels tested. * We plan to test how much of the drugs are in the patient's blood at different times, and the levels of certain proteins in their blood.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Clofarabine	Dose Escalation Schedule - Level 1: 1 mg daily x 5 days (orally) followed by 23 days off drug. Levels 2, 3, 4 and 5 are: 3, 5, 10 and 15 mg daily x 5 days followed by 23 days off drug.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-06-01
• Completion: 2013-10-01
• First posted: 2009-10-29
• Last updated: 2016-06-03

Locations

1 site across 1 country: United States