Desidustat in the Treatment of Chemotherapy Induced Anemia

• Status: Recruiting
• Trial end date: 2021-09-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, Open-label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for treatment of anemia in patients receiving chemotherapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Healthcare Limited

Criteria

Inclusion Criteria:

1. Diagnosis of non-myeloid malignancy.

2. Ability to comprehend and willingness to sign a written ICF for the study.

3. Male and Female patients at least 18 years old at the time of signing the ICF.

4. Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.

5. Subjects with eGFR >60 mL/min/1.73 meter sequre at screening.

6. Weight should be ≥50 kg.

7. Willingness to participate after informed consent.

8. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.

9. Ability to swallow and retain oral medication.

Exclusion Criteria:

1. Known hypersensitivity to Desidustat and excipients in the investigational drug product.

2. History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.

3. History of RBC transfusion <4 weeks prior enrollment.

4. History or presence of any clinically significant electrocardiogram abnormalities during screening.

5. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening

6. Major illness and/or major surgery in the last 3 months.

7. Planned elective surgery during the study

8. Receiving or has received any investigational drug within the 30 days before receiving Desidustat.

9. Any participants with poor peripheral venous access.

10. A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening visit.

11. Female patients with following criteria will not be recruited:

• History of pregnancy or lactation in the past 3 months

• Fertile female volunteers not protected against pregnancy by adequate long-term antifertility measures

• History of less than 1 year of menopause and not using adequate long-term anti-fertility measures

• Using hormone replacement therapy

• Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial

• Positive serum β-hCG level at the screening visit

12. Abnormal baseline laboratory investigations as follows:

• WBC count ≤ 3 x 103/uL

• Platelets count ≤ 100 x 103/uL

• Bilirubin ≥ 1.5 mg/dL

• ALT and/or AST ≥ 2.5 times of the ULN.