| CTRI Number |
CTRI/2025/09/094447 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Tablet Eltrombopag to prevent Decrease in the Platelet count in Patients with Solid Cancers receiving Gemcitabine based Cancer Treatment. |
|
Scientific Title of Study
|
A Comparative Study on Prophylactic use of Tablet Eltrombopag in varying doses to prevent Thrombocytopenia in Patients with Solid Tumour Malignancies receiving Gemcitabine based Chemotherapy : A Three armed, Prospective, Interventional Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chilamkurty Maitreyi |
| Designation |
D M Medical Oncology Post Graduate |
| Affiliation |
Stanley Medical College and Hospital,Chennai |
| Address |
Department of Medical oncology, Stanley Medical college,
SSB Block, OP No 53,
Old Jail road,
Washermanpet
Chennai
TAMIL NADU
600001
India |
| Phone |
9491969963 |
| Fax |
|
| Email |
maitreyi999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P N Sathiyamoorthy |
| Designation |
Professor and Head of the Department,Department of Medical Oncology |
| Affiliation |
Stanley Medical College and hospital,Chennai |
| Address |
Department of Medical oncology, Stanley Medical college,
SSB Block, OP No 53,
Old Jail road,
Washermanpet
Chennai
TAMIL NADU
600001
India |
| Phone |
9444221535 |
| Fax |
|
| Email |
sathiyamoorthypn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P N Sathiyamoorthy |
| Designation |
Professor and Head of the Department, Department of Medical Oncology, |
| Affiliation |
Stanley Medical College and Hospital,Chennai |
| Address |
Department of Medical oncology, Stanley Medical college,
SSB Block, OP No 53,
Old Jail road,
Washermanpet
Chennai
TAMIL NADU
600001
India |
| Phone |
9444221535 |
| Fax |
|
| Email |
sathiyamoorthypn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley Medical college,Chennai-01 |
|
|
Primary Sponsor
|
| Name |
Dr Chilamkurty Maitreyi |
| Address |
Department of Medical oncology, Stanley Medical college,
SSB Block, OP No 53,
Old Jail road,
Washermanpet,
Chennai. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrChilamkurty Maitreyi |
Government Stanley Medical college and Hospital |
Department of Medical oncology,Stanley Medical college,Ground floor,SS block, op no.53,old jail road, washermenpet, Chennai, 600001
Chennai
TAMIL NADU |
9491969963
maitreyi999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley Medical College and Hospital, Chennai-01,Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (3) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (4) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (5) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (6) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (7) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (8) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (9) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (10) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (11) ICD-10 Condition: C7A-C7A||Malignant neuroendocrine tumors, (12) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (13) ICD-10 Condition: C69-C72||Malignant neoplasms of eye, brain and other parts of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Observation |
Patients diagnosed with solid malignancies who are receiving Gemcitabine based chemotherapy will be under observation for 4 consecutive cycles. |
| Intervention |
Tab Eltrombopag 25 mg |
Patients diagnosed with solid malignancies who are receiving Gemcitabine based chemotherapy will receive Tablet Eltrombopag 25 mg orally daily for 7 days(Day 9-Day 15 of each cycle) for 4 consecutive cycles. |
| Intervention |
Tablet Eltrombopag 50mg |
Patients diagnosed with solid malignancies who are receiving Gemcitabine based chemotherapy will receive Tablet Eltrombopag 50 mg orally daily for 7 days(Day 9-Day 15 of each cycle) for 4 consecutive cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.In patients with Histologically/cytologically confirmed solid malignancies.
2.Patients with ECOG performance status 0-2.
3.Patients scheduled for Gemcitabine based chemotherapy (monotherapy or in combination).
4.Signed, written informed consent
5.Adequate organ function(as per standard laboratory values) |
|
| ExclusionCriteria |
| Details |
1.History of hematologic malignancy from bone marrow aspirate and biopsy or peripheral blood test in the prior 3 months.
2.Patients with pre-existing platelet count less than 1,00,000 cells/microL.
3.Patients with Active bleeding or coagulopathy.
4.Prior use of TPO receptor agonists
5.Patients with uncontrolled infection or uncontrolled Type 2 Diabetes Mellitus, Systemic Hypertension, chronic Diseases/ illness.
6.Pregnant women and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses whether prophylactic use of Tablet Eltromobopag in different doses reduce the degree and duration of Gemcitabine based chemotherapy induced thrombocytopenia
|
After 4 consecutive cycles of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether the Tablet Eltrombopag is safe and adverse effect profile. |
After every cycle for 4 consecutive cycles |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective study, patients aged more than 18years of age with solid malignancies scheduled for Gemcitabine based chemotherapy in any setting(Neo adjuvant,adjuvant ,palliative setting) will be included in the study.Gemcitabine Based Chemotherapy Will Be Given On Day 1 And Day8 Of Every 21 Day Cycle.One Day Prior To Every Chemotherapy Cycle CBC, RFTS, LFTS Will Be Checked. Patients will be taken under three arms.Arm A will receive Tablet Eltrombopag 50 mg orally daily for 7 days(Day 9-Day 15 of each cycle).Arm B will receive Tablet Eltrombopag 25 mg orally daily for 7 days(Day 9-Day 15 of each cycle).Arm C will be under observation(No Eltrombopag). Eltrombopag will be given as per assigned arm for 4 consecutive cycles will be given. Platelet counts trend will be observed across the 4 consecutive chemotherapy cycles. The efficacy of prophylactic use of Tablet Eltrombopagin various doses (25mg and 50mg) in preventing Gemcitabine based chemotherapy induced thrombocytopenia in patients with solid malignancies and Documentation of any chemotherapy Dose reductions or delays.Monitoring for adverse events and Toxicity will be assessed. |