search
Back to results

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

Primary Purpose

Anemia, Myelodysplastic Syndrome

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FG-4592
Placebo
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Myelodysplastic Syndromes, Anemia, Hemoglobin (Hb), Low Risk Myelodysplastic Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • ESA-naïve (less than 4 weeks of ESA treatment in total, and not within 30 days of Day 1)
  • ECOG of 0-2 at screen

Key Exclusion Criteria:

  • Diagnosis of secondary MDS
  • Significant myelofibrosis (>2+fibrosis)
  • Any prior therapy with antithymocyte globulin, azacitidine, or decitabine. Or Prior therapy with cyclosporine, thalidomide , or lenalidomide within 12 weeks prior to Day 1
  • Baseline erythropoietin level of >400 mIU/mL
  • Clinically significant anemia due to non-MDS etiologies

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • China-Japan Friendship Hospital
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Peking University Third Hospital
  • Xiyuan Hospital, CACMS
  • Fujian Medical University Union Hospital
  • Lanzhou University Second Hospital
  • Guangdong General Hospital
  • Nan Fang Hospital
  • Zhuzhou Central Hospital
  • Hainan Central Hospital
  • Second hospital of Hebei Medical University
  • Tumor Hospital of Henan province
  • Tongji Hospital, Tongji Medical College of HUST
  • Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog
  • The Third Xiangya Hospital of Central South University
  • Jiangsu Province Hospital
  • Zhongda Hospital Southeast University
  • The First Affiliated Hospital Of Soochow University
  • Northern Jiangsu People's Hospital
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Qilu Hospital of Shandong University
  • The Affiliated Hospital of Xuzhou Medical University
  • Huashan Hospital Affiliated to Fudan University
  • Shanghai Sixth People's Hospital
  • Shanghai Tongji Hospital
  • Shaanxi Provincial People's Hospital
  • The First Affiliated Hospital of Xi'an Jiao Tong University Medical College
  • Sichuan Provincial People's Hospital
  • West China Hospital, Sichuan University
  • Blood disease hospital of Chinese Academy of Medical Sciences
  • The Second Hospital of Tianjin Medical University
  • Tianjin Medical University General Hospital
  • First Affiliated Hospital of Kunming Medical University
  • The First Affiliated Hospital, Zhejiang University Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Phase 2 Part: FG-4592

Phase 3 Part: FG-4592

Phase 3 Part: Placebo

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
Change From Baseline in Mean Hb in Weeks 25 to 27
Percentage of Participants With Mean Hb ≥10.0 g/dL Within Any 8-week Period During the Study Without Transfusion
Number of Participants that Require Transfusions or Hb <6 g/dL 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

Full Information

First Posted
October 2, 2017
Last Updated
May 1, 2023
Sponsor
FibroGen
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT03303066
Brief Title
Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
Official Title
A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Myelodysplastic Syndrome
Keywords
Myelodysplastic Syndromes, Anemia, Hemoglobin (Hb), Low Risk Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Phase 2 part is an open label, single arm, dose-escalation study. Phase 3 component is a randomized, double blind, placebo-controlled study.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Part: FG-4592
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 3 Part: FG-4592
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 3 Part: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks.
Intervention Type
Drug
Intervention Name(s)
FG-4592
Other Intervention Name(s)
Roxadustat, AZD9941
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without Transfusion
Description
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 Outcome Measure Information:
Title
Number of Participants With Hb Increase ≥1.0 g/dL From Baseline
Description
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
Title
Time to First Hb Response
Description
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
Title
Change From Baseline in Mean Hb in Weeks 25 to 27
Time Frame
Baseline, Weeks 25 to 27
Title
Percentage of Participants With Mean Hb ≥10.0 g/dL Within Any 8-week Period During the Study Without Transfusion
Time Frame
26 weeks
Title
Number of Participants that Require Transfusions or Hb <6 g/dL up to Week 27
Time Frame
Up to Week 27
Title
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
Description
Frame: Baseline, Week 27
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Xiyuan Hospital, CACMS
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Nan Fang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
State/Province
Guangdong
Country
China
Facility Name
Hainan Central Hospital
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Second hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Tumor Hospital of Henan province
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital Of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shaanxi Provincial People's Hospital
City
Xian
State/Province
Shanxi
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiao Tong University Medical College
City
Xian
State/Province
Shanxi
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Blood disease hospital of Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs