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Efficacy and Safety of FG-459...

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

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2023-02-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anemia Myelodysplastic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Phase 2 part is an open label, single arm, dose-escalation study. Phase 3 component is a randomized, double blind, placebo-controlled study.

Study Groups

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Phase 2 Part: FG-4592

Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally 3 times a week (TIW) for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.

Group Type EXPERIMENTAL

FG-4592

Intervention Type DRUG

Oral

Phase 3 Part: FG-4592

Fixed starting doses (different doses for lower body weight \& higher body weight) of FG-4592 administered orally TIW for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.

Group Type EXPERIMENTAL

FG-4592

Intervention Type DRUG

Oral

Phase 3 Part: Placebo

Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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FG-4592

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Other Intervention Names

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Roxadustat AZD9941

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status