MDS
Conditions
Interventions
investigational material(s)
Generic name etc : FF-10501-01
INN of investigational material :
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational materi
Sponsors
Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
Fujifilm Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with MDS (including secondary MDS) according to the FAB classification. Patients with PS of 0 to 2. Patients whose organ functions except for bone marrow (cardiac, hepatic, pulmonary, and renal function, etc.) are sufficiently preserved, i.e., patients whose latest laboratory test values within 7 days prior to the first dosing meet all of the followings criteria (within 28 days prior to the first dosing for the resting 12-lead ECG) (ULN, upper limit of normal): Total bilirubin = 93% Patients with no abnormality requiring treatment on the resting 12-lead ECG Patients who cannot be expected to have therapeutic effect of existing treatment Patients with no plan to undergo stem cell transplantation. Patients who understand the requirements of the study and give consent in writing.
Exclusion criteria
Exclusion criteria: Patients who have been diagnosed with AML. Patients who have undergone hematopoietic stem cell transplantation. Patients who have underlying active infection. Patients who have taken another investigational drug within 90 days prior to the first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety safety | — |
Outcome results
None listed