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

Anemia Clinical Trial

Official title:

A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303066
• Other study ID #: FGCL-4592-813
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 6, 2018
• Est. completion date: February 8, 2023

Study information

• Verified date: April 2023
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 8, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• FG-4592
Oral
• Placebo
Oral

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Xiyuan Hospital, CACMS	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Nan Fang Hospital	Guangzhou	Guangdong
China	Hainan Central Hospital	Haikou	Hainan
China	The First Affiliated Hospital, Zhejiang University Medical College	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Affiliated Hospital of Xuzhou Medical University	Jinan	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai
China	Second hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital Of Soochow University	Suzhou	Jiangsu
China	Blood disease hospital of Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tongji Hospital, Tongji Medical College of HUST	Wuhan	Hubei
China	Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog	Wuhan	Hubei
China	Shaanxi Provincial People's Hospital	Xian	Shanxi
China	The First Affiliated Hospital of Xi'an Jiao Tong University Medical College	Xian	Shanxi
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Tumor Hospital of Henan province	Zhengzhou	Henan
China	Zhuzhou Central Hospital	Zhuzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
FibroGen	AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	Change From Baseline in Mean Hb in Weeks 25 to 27		Baseline, Weeks 25 to 27
Secondary	Percentage of Participants With Mean Hb =10.0 g/dL Within Any 8-week Period During the Study Without Transfusion		26 weeks
Secondary	Number of Participants that Require Transfusions or Hb <6 g/dL up to Week 27		Up to Week 27
Secondary	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	30 weeks