Chemotherapy Induced AnemiaPhase 2NCT04076943

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

A Phase 2 study testing Roxadustat in people with Chemotherapy Induced Anemia, run by Kyntra Bio at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chemotherapy Induced Anemia
What is being tested?: Roxadustat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 15 sitesUnited States
Study dates: 20 Aug 2019to 23 Apr 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Research Center
Ashland, Kentucky, 41101
Research Center
Bethesda, Maryland, 20817
Research Center
Canton, Ohio, 44718
Research Center
Covington, Louisiana, 70433
Research Center
Fort Wayne, Indiana, 46804
Research Center
Gettysburg, Pennsylvania, 17325
Research Center
Jacksonville, Florida, 32256
Research Center
Livingston, New Jersey, 07039
Research Center
Los Alamitos, California, 90720
Research Center
Los Angeles, California, 90024
Research Center
Philadelphia, Pennsylvania, 19106
Research Center
Plantation, Florida, 33322
Research Center
Port Jefferson Station, New York, 11776
Research Center
The Bronx, New York, 10469
Research Center
Torrance, California, 90505

Other trials in United States

About this study

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

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.

Read the detailed description

This study consists of three periods:

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

Conditions: Chemotherapy Induced Anemia
Being tested: Roxadustat
Keywords: Anemia, Chemotherapy induced anemia, Myelosuppressive chemotherapy, Non-Myeloid malignances
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RoxadustatDrug
Also called FG-4592
Roxadustat will be administered per schedule specified in the arm description.

Study groups in NCT04076943
Study group	Role	What they receive
Roxadustat	Experimental	Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks. Receives: Drug: Roxadustat

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, up to Week 16

Secondary outcomes (8)

Mean Change in Hb Level From Baseline to Week 16 (Without 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. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment.
Measured: Baseline, Week 16
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without 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.
Measured: Baseline, Weeks 9, 13, and 16
Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16
The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Measured: Baseline through Week 16
Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded.
Measured: Baseline through Week 16
Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16
The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Measured: Baseline through Week 16
Percentage of Participants Who Achieved a Hematopoietic Response
Hematopoietic response was defined as an increase in Hb of 1.5 g/dL from baseline or attaining a Hb of 11 g/dL. The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Measured: Baseline through Week 16
Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16
The 95% CI was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.
Measured: Baseline through Week 16
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16
Measured: Week 5 to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 201923 Apr 2021

First posted4 Sep 2019
Study start20 Aug 2019
Primary completion26 Mar 2021
Study completion23 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chemotherapy Induced AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04076943
Sponsor's protocol ID: FGCL-4592-092
Status last verified: Jun 2022
First submitted: 30 Aug 2019
Last updated: 3 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
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Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingPhase 2
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
Chemotherapy Induced Anemia
RecruitingPhase 1/2
Luspatercept for CIA in AML
Chemotherapy-inducing Anemia
RecruitingObservational study
Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
Cancer, Cancer-related Problem/Condition

All Chemotherapy Induced Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04076943
Acronym / sponsor ID: FGCL-4592-092
Conditions: Chemotherapy Induced Anemia
Keywords: Anemia, Chemotherapy induced anemia, Myelosuppressive chemotherapy, Non-Myeloid malignances
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Kyntra BioIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca, Astellas Pharma Inc
Study start: 20 Aug 2019 (actual)
Primary completion: 26 Mar 2021 (actual)
Study completion: 23 Apr 2021 (actual)
First posted: 4 Sep 2019 (actual)
Results: Posted 3 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Roxadustat	Experimental	Drug: RoxadustatParticipants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 16 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RoxadustatAlso: FG-4592Roxadustat will be administered per schedule specified in the arm description.	Drug	Roxadustat

Primary outcome

Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion
Time frame: Baseline, up to Week 16
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.

8 secondary outcomes

Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)
Time frame: Baseline, Week 16
Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)
Time frame: Baseline, Weeks 9, 13, and 16
Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Time frame: Baseline through Week 16
Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16
Time frame: Baseline through Week 16
Percentage of Participants Who Achieved a ≥1.5 g/dL Increase in Hb From Baseline Through Week 16
Time frame: Baseline through Week 16
Percentage of Participants Who Achieved a Hematopoietic Response
Time frame: Baseline through Week 16
Percentage of Participants Who Achieved a ≥2 g/dL Increase in Hb From Baseline Through Week 16
Time frame: Baseline through Week 16
Percentage of Participants Who Had an RBC Transfusion From Beginning of Week 5 (Day 29) to Week 16
Time frame: Week 5 to Week 16

Results and safety

Results posted to the registry on 3 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roxadustat	92	58

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

Time frame: Baseline, up to Week 16. Mean (Standard Deviation). Unit: g/dL

Measure	Roxadustat n = 89
Value	2.47 (1.510)

Population analysed: Full analysis set included all enrolled participants who received at least 1 dose of roxadustat, had a baseline Hb and at least 1 central lab Hb assessment during the treatment period.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 20. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roxadustat	40 of 92 (43.5%)	71 of 92 (77.2%)	17 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chemotherapy Induced Anemia

Not yet recruitingPhase 2
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
Chemotherapy-induced Anemia, Non-Myeloid Malignancy
Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingPhase 2
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
Chemotherapy Induced Anemia
RecruitingPhase 1/2
Luspatercept for CIA in AML
Chemotherapy-inducing Anemia
RecruitingObservational study
Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
Cancer, Cancer-related Problem/Condition

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roxadustat in people with Chemotherapy Induced Anemia, run by Kyntra Bio at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Change in Hb Within 16 Weeks From Baseline Without Red Blood Cell (RBC) Transfusion (time frame: Baseline, up to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04076943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.