Georgia's Online Cancer Information Center

Find A Clinical Trial

Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden

Status
Active
Cancer Type
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03263091
Protocol IDs
FGCL-4592-082 (primary)
NCI-2017-02071
Study Sponsor
FibroGen

Summary

The purpose of this study is to determine whether FG-4592 is safe and effective in the
treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood
Cell Transfusion Burden.

Objectives

This study includes an Open-Label Lead in, a Double-Blind component and an Open-Label High
Erythropoietin component. In each, there is an up to 42 days screen period followed by a
treatment period of 52 weeks and a 4 week end of treatment assessment.

Eligibility

  1. Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R classification to be made, and to show transfusion dependence.
  2. RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
  3. No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization
  4. Pre-transfusion hemoglobin of <= 10 g/dL,
  5. ECOG of 0-2 at screen
  6. History of cured malignancy with no evidence of recurrence for a least 3 years are eligible

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.