Desidustat in the Treatment of Chemotherapy Induced Anemia

NCT04667533 | Completed Phase 1

• 1 other identifier: DESI.20.001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia of Chronic Kidney Disease; Chemotherapy Effect

Keywords

Chemotherapy induced Anemia

Outcome Measures

Primary Outcomes (1)

• 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

  Change from Baseline to Day 7 and Day 30

Secondary Outcomes (1)

• Change of hemoglobin measurement from baseline

  Change from baseline to Day 7 and Day 30

Other Outcomes (9)

• Maximum plasma concentration (Cmax)

  Change from Baseline to 72 hours in blood

• Time to reach maximum plasma concentration (Tmax)

  Change from Baseline to 72 hours in blood

• Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)

  Change from Baseline to 72 hours in blood

Study Arms (1)

Desidustat tablet

EXPERIMENTAL

Drug: Desidustat

Interventions

Desidustat DRUG

A total of 24 participants will be enrolled. The study is divided into three cohorts as given below: 1. Cohort I: Single-dose 100 mg 2. Cohort II: Single-dose 150 mg 3. Cohort III: Single-dose 200 mg

Desidustat tablet

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

HCG Manavata Cancer Centre,

Nashik, Mahar Ashtra, 422002, India

Location

MeSH Terms

Interventions

desidustat

Study Officials

• Dr Deven Parmar, MD

  Cadila Healthcare Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 14, 2020
• Study Start: November 11, 2020
• Primary Completion: March 27, 2022
• Study Completion: May 10, 2022
• Last Updated: May 18, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)