Back to resultsDesidustat in the Treatment of Chemotherapy Induced Anemia
Primary Purpose
Anemia of Chronic Kidney Disease, Chemotherapy Effect
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Desidustat
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring Chemotherapy induced Anemia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- HCG Manavata Cancer Centre,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desidustat tablet
Arm Description
Outcomes
Primary Outcome Measures
To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
The Common Terminology Criteria for Adverse Event (CTCAE) (Version 4.03 or higher) system will be used for reporting and grading
Secondary Outcome Measures
Change of hemoglobin measurement from baseline
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
Full Information
NCT ID
NCT04667533
First Posted
November 9, 2020
Last Updated
May 17, 2022
Sponsor
Zydus Lifesciences Limited
1. Study Identification
Unique Protocol Identification Number
NCT04667533
Brief Title
Desidustat in the Treatment of Chemotherapy Induced Anemia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
March 27, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydus Lifesciences Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Cohort I: Single-dose 100 mg
Cohort II: Single-dose 150 mg
Cohort III: Single-dose 200 mg
Note:- After evaluation of PK data of 100 mg dose cohort, next cohort with higher dose will be decided. Maximum dose of Desidustat will not be exceeded than 200 mg.
First cohort will be given 100 mg single dose of Desidustat. On completion of safety and PK evaluation of first cohort,the next cohort with escalated single dose (150 mg) of Desidustat will be initiated. Similar way third cohort with 200 mg single dose will be initiated after safety evaluation of 150 mg cohort data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease, Chemotherapy Effect
Keywords
Chemotherapy induced Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desidustat tablet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Desidustat
Intervention Description
A total of 24 participants will be enrolled.
The study is divided into three cohorts as given below:
Cohort I: Single-dose 100 mg
Cohort II: Single-dose 150 mg
Cohort III: Single-dose 200 mg
Primary Outcome Measure Information:
Title
To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
Description
The Common Terminology Criteria for Adverse Event (CTCAE) (Version 4.03 or higher) system will be used for reporting and grading
Time Frame
Change from Baseline to Day 7 and Day 30
Secondary Outcome Measure Information:
Title
Change of hemoglobin measurement from baseline
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
Time Frame
Change from baseline to Day 7 and Day 30
Other Pre-specified Outcome Measures:
Title
Maximum plasma concentration (Cmax)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Time to reach maximum plasma concentration (Tmax)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Terminal half life (t1/2)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Elimination rate constant (λz)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Clearance (CL)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Volume of distribution (Vd)
Description
a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 hour post the single dose administration.
Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws.
Time Frame
Change from Baseline to 72 hours in blood
Title
Amount recovered in Urine
Description
Urine PK collection will occur relative to dosing of Desidustat at pre-dose (within 2 hours before dosing) and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance. Desidustat and the drug metabolite in urine and additional assay may be required.
Time Frame
Change from baseline to 24 hours in urine
Title
Percent recovered in urine
Description
Urine PK collection will occur relative to dosing of Desidustat at pre-dose (within 2 hours before dosing) and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance. Desidustat and the drug metabolite in urine and additional assay may be required.
Time Frame
Change from baseline to 24 hours in urine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Deven Parmar, MD
Organizational Affiliation
Cadila Healthcare Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
HCG Manavata Cancer Centre,
City
Nashik
State/Province
Mahar Ashtra
ZIP/Postal Code
422002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Desidustat in the Treatment of Chemotherapy Induced Anemia
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