Health Condition 1: null- Chemotherapy-Induced Thrombocytopenia
Conditions
Interventions
Intervention1: UPLATâ?¢: Route of administration- Oral
Dosage form- Capsule
Patients in the UPLATâ?¢ treatment group with
� Platelet counts between 20000 and 50000/µL (both inclusive) will take 4
Sponsors
Sanat Products Ltd
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years 2. Platelet counts between >= 20000 and 3. Confirmed solid tumour and received at least one cycle of chemotherapy prior to screening visit 4. No clinically significant derangement in liver and kidney function as assessed by standard laboratory parameters 5. International normalized ratio 6. An Eastern Cooperative Oncology Group performance status of 0 to 2 7. No prior history of platelet disorders or dysfunction and no history of a bleeding disorder 8. No physical limitation to ingest and retain oral medication 9. Willingness to participate after informed consent
Exclusion criteria
Exclusion criteria: 1. Received any thrombopoietic growth factor or related substancewithin 28 days prior to the pre-treatment visit 2. Has bone marrow involvement 3. Planning to receive any type of radiation therapy or surgery during study period 4. Received platelet transfusion within past 2 weeks prior to screening visit 5. Women who are pregnant or breast feeding 6. Participation in another trial of an investigational drug within 28 days prior to the pre-treatment visit 7. Any other clinically significant medical condition e.g. active infection, psychiatric condition, or laboratory abnormality which would, in the judgement of the Investigator, interfere with the patients ability to participate in the trial 8. Sepsis, disseminated coagulation, or any other condition that may exacerbate thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in platelet counts from baseline to end of treatment (EOT) Timepoint: baseline to end of treatment (EOT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse events (AEs) according to Common Terminology Criteria for Adverse Event version 4.0 Timepoint: From consenting of patients to the time when the patient is out of the study;Number of patients attaining platelets â?¥100000/µL at end of study (EOS)Timepoint: at end of study (EOS) | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed