Clinical trial NCT04076943: Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Official title: A Phase 2 Open Label Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy Induced Anemia
Keywords: Anemia
Chemotherapy induced anemia
Myelosuppressive chemotherapy
Non-Myeloid malignances
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
name: Astellas Pharma Inc
First posted: 2019-09-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study consists of three periods:

1. Screening Period up to 28 days
2. Treatment Period of up to16 weeks
3. A Follow-up period of 4 weeks.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Participants with cancer receiving chemotherapy when the anticipated outcome is cure
2. Participants who are only receiving hormonal products, biological products, cancer immunotherapy or radiation therapy to treat/manage their cancer
3. History of leukemia
4. Participants who have received an RBC transfusion or erythropoietic therapy within 4 weeks of enrollment
5. Use of any investigational drug within 8-weeks prior to treatment with roxadustat
6. Clinically significant anemia due to other etiologies
7. 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
8. Clinically significant or uncontrolled ongoing autoimmune disease (for example, rheumatoid arthritis, Crohn's disease, celiac disease, etc.)
9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection

Primary outcomes:
measure: Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
timeFrame: Baseline, up to Week 16
Secondary outcomes:
measure: Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)
timeFrame: Baseline, Week 16
measure: Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
timeFrame: Baseline, Weeks 9, 13, and 16
measure: Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16
timeFrame: Baseline through Week 16
measure: Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16
timeFrame: Baseline through Week 16
measure: Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16
timeFrame: Baseline through Week 16
measure: Percentage of Participants Who Achieved a Hematopoietic Response
timeFrame: Baseline through Week 16
measure: Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16
timeFrame: Baseline through Week 16
measure: Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16
timeFrame: Week 5 to Week 16
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Research Center
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Torrance
country: United States
facility: Research Center
state: California
city: Jacksonville
country: United States
facility: Research Center
state: Florida
city: Plantation
country: United States
facility: Research Center
state: Florida
city: Fort Wayne
country: United States
facility: Research Center
state: Indiana
city: Ashland
country: United States
facility: Research Center
state: Kentucky
city: Covington
country: United States
facility: Research Center
state: Louisiana
city: Bethesda
country: United States
facility: Research Center
state: Maryland
city: Livingston
country: United States
facility: Research Center
state: New Jersey
city: Bronx
country: United States
facility: Research Center
state: New York
city: Port Jefferson Station
country: United States
facility: Research Center
state: New York
city: Canton
country: United States
facility: Research Center
state: Ohio
city: Gettysburg
country: United States
facility: Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Center
state: Pennsylvania
Study officials:
References: