Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study (MACS1574)

March 1, 2017 updated by: Novartis Pharmaceuticals

A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Novartis Investigative Site
      • Limoges cedex, France, 87042
        • Novartis Investigative Site
      • Pessac Cedex, France, 33604
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, France, 54511
        • Novartis Investigative Site
    • Cedex
      • Caen, Cedex, France, 14033
        • Novartis Investigative Site
  • Italy
      • Roma, Italy, 00133
        • Novartis Investigative Site
    • AL
      • Alessandria, AL, Italy, 15100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • South Africa
      • Bloemfontein, South Africa, 901
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28033
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent prior to any screening procedures
  • Male or female patients ≥ 18 years of age
  • Patient must weigh between 45-135 kg
  • Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score or RA, RARS by WHO criteria. IPSS must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable

Deferasirox naïve:

Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation

Exclusion Criteria:

  • History or current GI disease
  • Systemic diseases which could prevent study treatments
  • Left ventricular ejection fraction< 50 % by echo cardiography
  • Serum creatinine > 1.2 x ULN at screening
  • Platelet counts < 25x 109/L except in cases where guidance is already given in the local deferasirox label
  • AST or ALT > 2.5 xULN at screening

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deferasirox am
Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
Drug: Deferasirox
Other Names:
  • ICL670
Experimental: Deferasirox pm
Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
Drug: Deferasirox
Other Names:
  • ICL670

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms
Time Frame: 3 months
Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.
Time Frame: 6 months
Study was prematurely terminated and not powered for efficacy.
6 months
Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups
Time Frame: months 3 and 6.
Study was prematurely terminated and not powered for efficacy.
months 3 and 6.
Difference in Severity of Overall GI AEs Between the Two Treatment Groups
Time Frame: months 3 and 6.
Study was prematurely terminated and not powered for efficacy.
months 3 and 6.
Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups
Time Frame: months 3 and 6
Study was prematurely terminated and not powered for efficacy.
months 3 and 6
Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups
Time Frame: months 3 and 6
Study was prematurely terminated and not powered for efficacy.
months 3 and 6
the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups
Time Frame: 3 months, 6 months
Study was prematurely terminated and not powered for efficacy.
3 months, 6 months
Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups
Time Frame: 3 months, 6 months
3 months, 6 months
Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups
Time Frame: 3 months, 6 months
Study was prematurely terminated and not powered for efficacy.
3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670A2417
  • 2011-001077-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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