Health Condition 1: D64- Other anemias
Conditions
Interventions
Intervention1: Desidustat Oral tablets 120 mg: The subjects will receive study drug orally, thrice in a week for 12 weeks for treatment of chemotherapy induced anemia in patients with solid tumor mali
Sponsors
Zydus Lifesciences Ltd.
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female (Age greater than or equals to 18) 2. Body weight greater than or equals to 45 kg at screening 3. Confirmed diagnosis of solid tumor malignancy (based on historical document such as histopathology report and current documentation of the disease by imaging modality performed within 03 months prior to screening 4. Anemia caused by myelosuppressive chemotherapy defined as hemoglobin level 8 to 10 g/dL (both inclusive) assessed at screening (Patient must have received at least one cycle of myelosuppressive chemotherapy irrespective of the treatment regimen within 28 days prior to screening) (Refer Annexure No. III) 5. ECOG performance status of 0 to 2 at screening 6. Planned concurrent treatment of cancer with myelosuppressive chemotherapy for at least 08 additional weeks irrespective of frequency of cycles 7. Estimated life expectancy greater than or equals to 6 months at enrolment 8. Adequate iron status defined as serum Ferritin level greater than or equals to 100 ng/mL and transferrin saturation (TSAT) greater than or equals to 20 percent at screening. 9. Men and women of childbearing potential must agree to use adequate birth control measures during the study. Acceptable methods of birth control in this study include - surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partners vasectomy, double-barrier method (condom or diaphragm with spermicide) during study participation and for 30 days after their last dose of study drug. 10. Participants must be capable of giving written informed consent. Understand and sign informed consent be willing to comply with all study procedures. In case of illiterate patients, thumb impression of the patients will be obtained along with the signature of the impartial witness on the consent form prior to patients participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients who are receiving only hormonal products, novel immunosuppressive therapy, or targeted biological therapy or radiation therapy to treat their cancer 2. Patients who have received an RBC transfusion or erythropoietin therapy within 4 weeks prior to randomization 3. Patients who preferred a red blood cell (RBC) transfusion for treatment of anemia at time of study entry over receiving the study drug (Desidustat) 4. Participants who have participated in clinical trial of any investigational product or medical device within 3 months prior to screening other than the present trial. 5. Clinically significant Vitamin B12 or Folic acid deficiency assessed at screening 6. Serologic status assessed at screening that reflect active infection with HBV, HCV or HIV. 7. Female participants with any of one of the following criteria: a. History of pregnancy or lactation within three months prior to screening b. Positive serum beta-HCG test at screening c. History of amenorrhea for less than 1 year and not using adequate antifertility measures 8. Abnormal baseline laboratory investigations as follows: a. Total WBC count less than or equals to 2 x 103/microL b. Platelets count less than or equals to 100 x 103/microL c. Absolute Neutrophil Count less than or equals to 1000/microL d. ALT and/or AST greater than or equals to 2.5 times of the ULN and Total bilirubin greater than 1.5 times of ULN In participants with metastatic lesions in liver, AST/ALT level greater than 5 times ULN shall be excluded e. Total bilirubin greater than 2 times of ULN f. HbA1c greater than 9 percent 9. History of significant heart disease, including New York Heart Association Class III or IV congestive heart failure, uncontrolled hypertension or hypotension, or significant valvular or endocardial disease that would put the patient at risk for thromboembolism 10. History of thromboembolic event (deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, or transient ischemic attack) within previous 6 months prior to screening 11. History of leukemia 12. History of clinically significant anemia due to other aetiologies such autoimmune or hereditary hemolysis or anemia, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia 13. Clinically significant or uncontrolled ongoing autoimmune disease (e.g., rheumatoid arthritis, Crohns disease, celiac disease, etc.) 14. Major surgery within 90 days prior to randomization, and minor surgery within 30 days of prior to randomization or planned surgery during the study period 15. History of severe allergic or hypersensitivity reaction to investigational products and its excipients 16. Medical, psychological or behavioural conditions, which in the opinion of the investigator, may preclude safe participation, confound study interpretation, interfere with compliance, or preclude informed consent. 17. History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day). 18. Unable to swallow tablets or disease significantly affected gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Desidustat oral tablet in comparison to placebo for the treatment of chemotherapy induced anemia.Timepoint: Mean change in hemoglobin level - Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| A. To evaluate the additional and indirect parameters of efficacy of Desidustat oral tablet compared to placebo. B. To evaluate safety of Desidustat oral tablet compared to placebo during the trial.Timepoint: A. 1. Mean of maximum increase from baseline in hemoglobin level without rescue therapy in Desidustat arm compared to placebo arm (Time frame - baseline to Week 12) 2. Proportion of participants achieving Hemoglobin response defined as an increase of at least 1 g/dL from baseline in Desidustat arm compared to placebo arm by Week 12 3. Proportion of participants requiring rescue therapy in Desidustat arm compared to placebo arm (Time frame - baseline to Week 12) 4. Median time to achieve target hemoglobin level (greater than or equals to 11 g/dL) in Desidustat arm compared to placebo arm (Time frame - Baseline to Week 12) B. 1. Evaluation of safety as assessed by proportion of participants experiencing TEAEs, SAE as well as significant changes in physical examination, vitals or safety laboratory parameters from baseline to Week 12 | — |
Countries
India
Contacts
Public ContactMr Hitesh Maheshwari
Cliantha Research Limited
Outcome results
None listed