A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

FibroGen

Status and phase: Completed; Phase 3

Conditions: Chemotherapy Induced Anemia

Treatments: Drug: SEPO®; Drug: Roxadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05301517

FGCL-4592-898

Details and patient eligibility

About

The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.

Full description

Participants who are eligible for participation will be randomized to roxadustat and SEPO® (recombinant human erythropoietin-α [rHuEPO-α]), and undergo a 12-week treatment period followed by a 4-week follow-up period.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of non-myeloid malignancy, by histological or cytological confirmation.
• Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged by the investigator.
• Planned concurrent treatment of cancer (myelosuppressive chemotherapy) for at least 8 additional weeks.
• Body weight ≥40 kg.
• Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2.
• Ferritin ≥50 nanograms (ng)/milliliter (mL) and transferrin saturation (TSAT) ≥10%.

Key Exclusion Criteria:

• Participants with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• Participants who are only receiving hormonal products, biological products, novel immunosuppressive products (such as programmed cell death protein-1 [PD-1] and programmed death-ligand 1 [PD-L1] checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer, however if chemotherapy is co-administered with these products, then it is acceptable to enroll the participant.
• Participants with hematocrit (HCT) ≥36%.
• Participants who have received an RBC transfusion or ESA within 4 weeks of randomization.
• Thromboembolic event (including but not limited to deep vein thrombosis [DVT], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack [TIA] within previous 6 months of screening.
• Clinically significant anemia due to other etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia.
• The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical conditions.

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Roxadustat

Experimental group

Description:

Participants will receive roxadustat, administered orally 3 times per week (TIW) for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be based on the participant's weight group. The maximum dose for individual participants may not exceed 3.5 milligrams (mg)/kilogram (kg) or 400 mg TIW whichever is lower.

Treatment:

Drug: Roxadustat

SEPO®

Active Comparator group

Description:

Participants will receive SEPO®, injected subcutaneously TIW for 12 weeks to achieve Hb levels of 100-120 g/L. The starting dose will be 150 international units (IU)/kg subcutaneously TIW.

Treatment:

Drug: SEPO®