MedTrace Logo

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

NCT01003678 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-06-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Wetzler Meir, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-06-30
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01003678 on ClinicalTrials.gov