Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

NCT04076943 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FGCL-4592-092
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and effective for the treatment of anemia in participants receiving chemotherapy treatment for cancer.

Conditions

Chemotherapy Induced Anemia

Keywords

Anemia; Chemotherapy induced anemia; Myelosuppressive chemotherapy; Non-Myeloid malignances

Outcome Measures

Primary Outcomes (1)

• Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion

  Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. All central lab assessments from Day 1 to end of treatment (EOT) or early termination (ET) were included in the evaluation of this endpoint. Hb values within 4 weeks after an RBC transfusion were excluded.

  Baseline, up to Week 16

Secondary Outcomes (8)

• Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)

  Baseline, Week 16

• Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)

  Baseline, Weeks 9, 13, and 16

• Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16

  Baseline through Week 16

• Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16

  Baseline through Week 16

• Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16

  Baseline through Week 16

Study Arms (1)

Roxadustat

EXPERIMENTAL

Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks.

Drug: Roxadustat

Interventions

Roxadustat DRUG

Roxadustat will be administered per schedule specified in the arm description.

Also known as: FG-4592

Roxadustat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of non-myeloid malignancy
• Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0 grams (g)/deciliter (dL) at screening
• Planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks
• Estimated life expectancy ≥ 6 months at enrollment (Day 1)

You may not qualify if:

• Participants with cancer receiving chemotherapy when the anticipated outcome is cure
• Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer
• History of leukemia
• Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
• Use of any investigational drug within 8-weeks prior to treatment with roxadustat
• Clinically significant anemia due to other etiologies
• Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (for example, deep vein thrombosis \[DVT\] or pulmonary embolism) within previous 6 months of screening
• Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
• Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection

Sponsors & Collaborators

• Kyntra Bio: lead
• AstraZeneca: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (15)

Research Center

Los Alamitos, California, 90720, United States

Location

Research Center

Los Angeles, California, 90024, United States

Location

Research Center

Torrance, California, 90505, United States

Location

Research Center

Jacksonville, Florida, 32256, United States

Location

Research Center

Plantation, Florida, 33322, United States

Location

Research Center

Fort Wayne, Indiana, 46804, United States

Location

Research Center

Ashland, Kentucky, 41101, United States

Location

Research Center

Covington, Louisiana, 70433, United States

Location

Research Center

Bethesda, Maryland, 20817, United States

Location

Research Center

Livingston, New Jersey, 07039, United States

Location

Research Center

Port Jefferson Station, New York, 11776, United States

Location

Research Center

The Bronx, New York, 10469, United States

Location

Research Center

Canton, Ohio, 44718, United States

Location

Research Center

Gettysburg, Pennsylvania, 17325, United States

Location

Research Center

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

FG4592-092Study@fibrogen.com

415-978-1441

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 4, 2019
• Study Start: August 20, 2019
• Primary Completion: March 26, 2021
• Study Completion: April 23, 2021
• Last Updated: June 3, 2022
• Results First Posted: June 3, 2022

Record last verified: 2022-06

Locations

US (15)