Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Vomiting

Constipation

Diarrhea

Pain

Abdominal Pain

Iron Overload

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Metabolic Diseases

Iron Metabolism Disorders

Micronutrients

All Drugs and Chemicals

Iron

Deferasirox

Chelating Agents

Iron Chelating Agents

Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food

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

Novartis Pharmaceuticals

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.

Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

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.

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.

Study was prematurely terminated and not powered for efficacy.

ICL am

ICL pm

Deferasirox am

Deferasirox pm

Total

Age, Continuous

Sex: Female, Male

Study Director

Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms

Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.

Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups

Difference in Severity of Overall GI AEs Between the Two Treatment Groups

Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups

Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups

the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups

Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups

Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups

Overall Study

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

Midostaurin

Protein Kinase Inhibitors

Enzyme Inhibitors

LGH447 monotherapy in patients with AML or MDS

LGH447 + midostaurin in patients with AML

LGH447

LGH447 + midostaurin

This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.

A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Frequency and characteristics of dose limiting toxicities

Includes changes in hematology and blood chemistry values, assessments of physical examinations, vital signs, and electrocardiograms (ECGs)

LGH447 and midostaurin plasma concentrations and basic PK parameters

To assess any preliminary anti-tumor activity in AML or high risk MDS associated with LGH447

To assess any preliminary anti-tumor activity in AML or high risk MDS associated with LGH447 in combination with midostaurin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study	NCT01326845	Myelodysplastic... Transfusional I...	Deferasirox	18 Years -	Novartis
A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)	NCT02078609	AML and High Ri...	LGH447 LGH447 + midost...	18 Years -	Novartis

Spots Global Cancer Trial Database for myelodysplastic syndrome,