Status:
COMPLETED
Desidustat in the Treatment of Chemotherapy Induced Anemia
Lead Sponsor:
Zydus Lifesciences Limited
Conditions:
Anemia of Chronic Kidney Disease
Chemotherapy Effect
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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.
Detailed Description
A total of up to approximately 24 patients will be enrolled to receive Desidustat in an open-label manner. The study is divided into three cohorts as given below: 1. Cohort I: Single-dose 100 mg 2. ...
Eligibility Criteria
Inclusion
- Diagnosis of non-myeloid malignancy.
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male and Female patients at least 18 years old at the time of signing the ICF.
- Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.
- Subjects with eGFR \>60 mL/min/1.73 meter sequre at screening.
- Weight should be ≥50 kg.
- Willingness to participate after informed consent.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Ability to swallow and retain oral medication.
Exclusion
- Known hypersensitivity to Desidustat and excipients in the investigational drug product.
- History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
- History of RBC transfusion \<4 weeks prior enrollment.
- History or presence of any clinically significant electrocardiogram abnormalities during screening.
- 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
- Major illness and/or major surgery in the last 3 months.
- Planned elective surgery during the study
- Receiving or has received any investigational drug within the 30 days before receiving Desidustat.
- Any participants with poor peripheral venous access.
- A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening visit.
- 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
- 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.
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04667533
Start Date
November 11 2020
End Date
May 10 2022
Last Update
May 18 2022
Active Locations (1)
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1
HCG Manavata Cancer Centre,
Nashik, Mahar Ashtra, India, 422002