Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)

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Overview

The objective of this study to evaluate the efficacy FG-4592 for the treatment of anemia in Chinese participants with lower risk MDS.

This is a Phase 2/3 trial with sequential Phase 2 and Phase 3 components. In each part, there is an up to 4 weeks screening period followed by a treatment period of 26 weeks and a 4 week follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anemia Myelodysplastic Syndrome

Interventions

FG-4592DRUG

Oral

PlaceboDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Diagnosis of primary MDS classified as very low, low or intermediate risk with \<5% blasts (documented within 12 weeks prior to Day 1) * Screening Hb \<10 g/dL and ≥6g/dL * Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1 * Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1) * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 Key Exclusion Criteria: * Diagnosis of secondary MDS * Significant myelofibrosis (\>2+fibrosis) * Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1 * Baseline erythropoietin level of \>400 units (U)/liter (L) * Clinically significant anemia due to non-MDS etiologies Note: Other inclusion and exclusion criteria may apply.

Locations (38)

Outcomes

Primary Outcomes

Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without Transfusion

Hemoglobin response to FG-4592 is defined as an increase in mean Hb of ≥1.0 grams (g)/deciliter (dL) from baseline within any 8-week period during the study without transfusion.

Time frame: 26 weeks

Secondary Outcomes

Number of Participants With Hb Increase ≥1.0 g/dL From Baseline

Hb response to FG-4592 is defined as an increase in mean Hb of ≥1.0 g/dL from baseline within any 8-week period during the study without transfusion.

Time frame: 26 weeks

Time to First Hb Response

Hb response to FG-4592 is defined as an increase in mean Hb of ≥1.0 g/dL from baseline within any 8-week period during the study without transfusion.

Time frame: 26 weeks

Change From Baseline in Mean Hb in Weeks 25 to 27

Time frame: Baseline, Weeks 25 to 27

Percentage of Participants With Mean Hb ≥10.0 g/dL Within Any 8-week Period During the Study Without Transfusion

Time frame: 26 weeks

Number of Participants that Require Transfusions or Hb <6 g/dL up to Week 27

Time frame: Up to Week 27

Mean Change From Baseline in Functional Assessment of Cancer Therapy - Anemia (FACT-An) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores at Week 27

Frame: Baseline, Week 27

Time frame: 30 weeks

Data from ClinicalTrials.gov

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

China-Japan Friendship Hospital