Temsirolimus in Myelodysplastic Syndrome (MDS)

NCT01111448 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-02-13

No results posted yet for this study

Summary

The goal of this Pilot-study is to evaluate the response of unselected MDS patients to temsirolimus a drug approved for the treatment of renal cell cancer. It is planned to give temsirolimus at a weekly dose of 25 mg as intravenous infusion for a maximum duration of 12 months. Regular bone marrow biopsies are planned for controlling MDS response.

Conditions

Interventions

DRUG

Temsirolimus

25 mg/day 1; 8; 15; 22 of each 28-day cycle as intravenous infusion over 30 min

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY
  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Uwe Platzbecker, MD, PhD · Medizinische Klinik I, Universitätsklinikum Carl-Gustav-Carus, Dresden, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-06-30
Completion
2014-06-30

Countries

  • Germany

Study Locations

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Entities

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 NCT01111448 on ClinicalTrials.gov